MRI Compatibility for Existing Straumann Dental Implant Systems

K190662 · Straumann USA, LLC · DZE · Jun 17, 2019 · Dental

Device Facts

Record IDK190662
Device NameMRI Compatibility for Existing Straumann Dental Implant Systems
ApplicantStraumann USA, LLC
Product CodeDZE · Dental
Decision DateJun 17, 2019
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended Use

ITI self-tapping implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.

Device Story

The device is a modification to existing Straumann Dental Implant Systems to establish MRI compatibility. It consists of dental implants and prosthetic accessories (abutments, copings, healing caps, closure screws) used in dental clinics by dentists/oral surgeons. The device provides a base for prosthetic restorations (crowns, bridges, overdentures) to restore chewing function. The modification ensures the implants and components are safe for use in an MRI environment. The healthcare provider uses the device to surgically place implants and attach prosthetic components, facilitating patient rehabilitation. The primary benefit is allowing patients with these implants to undergo MRI procedures safely.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Dental implants and prosthetic accessories (abutments, copings, healing caps, closure screws) made of titanium or titanium alloy. The device is a mechanical system for endosseous dental implantation. No software or electronic components are involved.

Indications for Use

Indicated for edentulous or partially edentulous patients requiring dental implants for support of crowns, bridges, or overdentures in maxillary or mandibular arches. Includes immediate, delayed, or conventional placement. Specific contraindications include limited interdental space or restricted bone for certain anterior implants.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 17, 2019 Straumann USA LLC Loretta Kushner-Mooney Sr. Director RA/QA NAM 60 Minuteman Road Andover, Massachusetts 01810 Re: K190662 Trade/Device Name: MRI Compatibility for Existing Straumann Dental Implant Systems Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA, OAT, DZL Dated: March 19, 2019 Received: March 20, 2019 Dear Loretta Kushner-Mooney: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems ### Indications for Use (Describe) Modification to ITI DENTAL IMPLANT SYSTEM ITI self-tapping implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------|--| | <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | | | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {3}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) ITI DENTAL IMPLANT SYSTEM ITI solid screw implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {4}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) ITI DENTAL IMPLANT SYSTEM The ITI anterior implant is intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the anterior implant is indicated for replacement of single lateral incisors in maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited ( minimum 5 mm) and where vestibulo-oral bone is restricted (minumum 5 mm). The anterior implant can also be used as a support for a full arch implant-borne restoration, but only in conjunction with a standard ITT 4.1mm dental implant. X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {5}------------------------------------------------ 510(k) Number (if known) K190662 #### Device Name MRI Compatibility for Existing Straumann Dental Implant Systems ### Indications for Use (Describe) ITI DENTAL IMPLANT SYSTEM ITI® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandbular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------|--------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {6}------------------------------------------------ 510(k) Number (if known) K190662 #### Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM The abutment is placed in the dental implant to provide support for a prosthetic restoration such as a crown or bridge. The titanium temporary posts are screwed into the dental implants and serve as a base for a temporary prosthetic restoration. The plastic burn-out copings provide a cast inner surface for mating with the abutment and are for use in casting restorations directly from porcelain-fused-to-metal alloy without the use of machined metal components. The healing cap and closure screw are titanium devices which are mounted onto the soft tissue is sutured in place around the implant and which are intended to protect the inner configuration of the implant. The healing cap also protects the outer 45 degree shoulder of the healing phase and helps stabilize and maintain the soft tissue. | Type of Use (Select <i>one</i> or <i>both</i> , as applicable) | | |----------------------------------------------------------------|--| |----------------------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {7}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT The ITI synOcta angled abutments for Wide Neck Implants are in cases where the placement of an implant requires an angled reconstruction for an optimal result. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><span><div style="border: 1px solid black; width: 10px; height: 10px; display: flex; justify-content: center; align-items: center;">X</div></span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span><div style="border: 1px solid black; width: 10px; height: 10px; display: flex; justify-content: center; align-items: center;"></div></span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {8}------------------------------------------------ 510(k) Number (if known) K190662 #### Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM Abutments are intended to be placed in the dental implant to provide support for a prosthetic restorations such as crowns or bridges. The ITI esthetic are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations. Type of Use (Select one or both, as applicable) | <span style="text-decoration: underline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------------------| | <span style="text-decoration: underline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {9}------------------------------------------------ 510(k) Number (if known) K190662 #### Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM The abutment is placed in a dental implant to provide support for a prosthetic restoration such as a crown or bridge. Type of Use (Select one or both, as applicable): | <label> <input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </label> | |-----------------------------------------------------------------------------------------------------------------| | <label> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </label> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {10}------------------------------------------------ 510(k) Number (if known) K190662 #### Device Name MRI Compatibility for Existing Straumann Dental Implant Systems ### Indications for Use (Describe) ITI DENTAL IMPLANT SYSTEM ITI® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandbular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|---------------------------------------------| | <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {11}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems ### Indications for Use (Describe) ITI DENTAL IMPLANT SYSTEM ITI® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandbular arches to support crowns, bridges, or overdentures in edentulous patients. The ITI Dental Implants are for single-stage or two-stage surgical procedures. Type of Use (Select one or both, as applicable) | <span style="font-size: 12px;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |----------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 12px;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {12}------------------------------------------------ 510(k) Number (if known) K190662 #### Device Name MRI Compatibility for Existing Straumann Dental Implant Systems ### Indications for Use (Describe) DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM) The device that is the subject of this submission is an angled titanium coping, which is a pre-manufactured component offering a pre-formed inner surface for mating with the dental implant abutment. The outer surface of the coping can be adapted to the individual restoration. The coping is angled and is used only with the ITI anterior implant. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {13}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) ITI SYNOCTA MESO ABUTMENTS Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The ITI provide synOcta Measo abutments and indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used in single tooth replacements and tooth restorations. Type of Use (Select one or both, as applicable) | | <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |--|-------------------------------------------------------------| | | <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {14}------------------------------------------------ 510(k) Number (if known) K190662 #### Device Name MRI Compatibility for Existing Straumann Dental Implant Systems ### Indications for Use (Describe) MODIFICATION TO ITI DENTAL IMPLANT SYSTEM ITI implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. ITI Dental Implants are for single-stage surgery. ITI Dental Implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {15}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems Indications for Use (Describe) Straumann Dental Implant System The ITI Dental System implants are for single-stage or two-stage surgical procedures. The ITI Dental System implants are intended for immediate placement and function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediately loaded cases. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {16}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems Indications for Use (Describe) The Straumann Ortho implant system The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal or promedion area of the hard palate or in retromolor positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed ofter orthodontic treatment has been completed. Ortho implants con be used in adults and juveniles (age 12 and older). In case of patients who have not yet completed skeletal growth (e.g. as shown by radiographic analysis of the hand/wrist), the ortho implant should be placed off the mid-line in the paramedian region of the palate in order to avoid the rnid-palatal suture. X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {17}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems Indications for Use (Describe) Elliptic Matrix The Elliptic Matrix is attached onto the Straumann Retentive Anchor abutment to provide support and retention for an overdenture. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) | |_ | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {18}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems Indications for Use (Describe) Straumann Temporary Coping The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {19}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT Abutments are intended to be placed into dental bridges to provide support for prosthetic reconstructions such as crowns or bridges. Type of Use (Select one or both, as applicable) | <span style="font-size:12px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | |------------------------------------------------------------------------------------| | <span style="font-size:12px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {20}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems ### Indications for Use (Describe) RN SYNOCTA TEMPORARY MESO ABUTMENT RN SynOcta Temporary Meso Abutments are for use in RN Straumann Dental Implants (04.8mm) for temporary restoration of single crowns in the anterior and posterior region for use up to six months. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------|-----------------------------------------| | <span style="text-decoration: underline;">Prescription Use</span> (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☑</span> | | Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">☐</span> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {21}------------------------------------------------ 510(k) Number (if known) K190662 #### Device Name MRI Compatibility for Existing Straumann Dental Implant Systems ### Indications for Use (Describe) STRAUMANN COMPUTER AIDED RESTORATION SERVICE Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Titanium Abutment is indicated for cemented restorations. The abutment can be used in single tooth replacements and multiple tooth restorations. Type of Use (Select one or both, as applicable) | <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |-----------------------------------------------------------------------------|----------------------------------------------------------------------------| |-----------------------------------------------------------------------------|----------------------------------------------------------------------------| ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {22}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems Indications for Use (Describe) Straumann OrthoSytsem The Straumann Palatal implant is intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for the attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended after orthodontic treatment has been completed. Palatal implants can be used in adults and juveniles age 12 and older. In case of patients who have not yet completed skeletal growth (e.g. as shown by radiographic analysis of the hand/wrist), the palatal implants should be placed off the mid-line in the paramedian region of the palate in order to avoid the mid-palatal suture. X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {23}------------------------------------------------ 510(k) Number (if known) K190662 #### Device Name MRI Compatibility for Existing Straumann Dental Implant Systems Indications for Use (Describe) Straumann Dental Implants Straumann Regular Neck and Narrow Neck implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used. The Straumann Regular Neck Implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations or partially edentulous patients for single-stage or two-stage surgery. The Straumann Narrow Neck implants are intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the Narrow Neck implant is indicated for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited (minimum 5 mm) and where vestibule-oral bone is restricted (minimum 5 mm). The Narrow Neck implant can also be used as a support for a full arch implant-born restoration, but only in conjunction with a standard Straumann 4.1 mm dental implant. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {24}------------------------------------------------ 510(k) Number (if known) K190662 #### Device Name MRI Compatibility for Existing Straumann Dental Implant Systems ### Indications for Use (Describe) STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING Copings are intended to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Ceramic Coping is indicated for cemented restorations. The coping can be used in single tooth replacements and multiple tooth restorations. Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {25}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems Indications for Use (Describe) P.004 Implants The P.004 Implants are intended for immediate, delayed or conventional placement in the maxilla and/or mandbular arches to support crowns bridges or overdentures in edentulous or partially edentulous patients. They are intended for immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. Mesa abutments are indicated for cemented restorations particularly in esthetic areas of the mouth. The abutment can be used in single tooth replacements and multiple tooth restorations. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {26}------------------------------------------------ 510(k) Number (if known) K190662 #### Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) WN SYNOCTA GOLD ABUTMENT Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <span style="font-size: 10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 10pt;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {27}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) P.004 RC TEMPORARY ABUTMENT P.004 TEMPORARY HEALING ABUTMENT (CAP) P.004 RC Temporary Abutment is indicated for use in Straumann P.004 RC Bone Level implants for temporary restorations of single crowns and bridges for up to six months. P.004 Healing Abutment, customizable (cap) is indicated for use in Straumann P.004 RC Bone Level implants to protect the inner configuration of the implant during the healing process. Maintains, stabilizes and forms the soft tissue and should be placed out of occlusion for up to six months. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {28}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) STRAUMANN P.004 RC GOLD ABUTMENT Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|---------------------------------------------| | <span style="text-decoration: underline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {29}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) NARROW NECK TEMPORARY COPING The Narrow Neck Temporary Coping acts as a basis for the fabrication of individual temporary restorations and small cemented temporary bridges on Straumann Standard Plus Implants 03.3mm Narrow Neck for use up to six months. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {30}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) P.004 NC ANATOMIC ABUTMENTS Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations. | Type of Use (Select one or both, as applicable) | |--------------------------------------------------------------------------------------| | <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | | <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {31}------------------------------------------------ 510(k) Number (if known) K190662 #### Device Name MRI Compatibility for Existing Straumann Dental Implant Systems ## Indications for Use (Describe) P.004 HEALING ABUTMENTS AND CLOSURE SCREWS P.004 Healing Abutments and Closure Screws are intended for use with the Straumann P.004 Bone Level Implant system to protect the inner configuration of the implant. Healing Abutments have a secondary function to maintain, stabilize and form the soft tissue during the healing process. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|-----------------------------------------------| | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {32}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| | | X Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {33}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems Indications for Use (Describe) P.004 ABUTMENTS Both the P.004 RC/NC Gold Abutment for Bars and RC/NC Titanium Abutment for Bars are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {34}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) STRAUMANN P.004 CEMENTABLE ABUTMENTS TEMPORARY COPINGS AND PROTECTIVE CAPS Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Protective Caps are intended to protect the outer configuration of the abutment and condition the contours of the soft tissue during the healing phase for up to 6 months. Temporary Copings are intended to serve as a base for temporary restorations for up to 28 days. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {35}------------------------------------------------ 510(k) Number (if known) K190662 #### Device Name MRI Compatibility for Existing Straumann Dental Implant Systems ### Indications for Use (Describe) P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns or bridges. The P.004 RC CARES Titanium Abutment is indicated for cemented restoration. The abutment can be used in single tooth replacements and multiple tooth restorations. Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns or bridges. The P.004 RC CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw retained. | Type of Use ( <i>Select one or both, as applicable</i> ) | | |----------------------------------------------------------|--| |----------------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {36}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) P.004 NC GOLD ABUTMENT FOR CROWNS Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Type of Use (Select one or both, as applicable) | <div> <object data="checkbox_checked.svg" height="15" type="image/svg+xml" width="15"></object> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |-------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <object data="checkbox_unchecked.svg" height="15" type="image/svg+xml" width="15"></object> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {37}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems Indications for Use (Describe) P.004 ABUTMENTS P.004 NC Temporary Abutment is indicated for use in Straumann P.004 NC Bone Level implants for temporary restorations of single crowns and bridges for up to six months. P.004 NC Healing Abutment, customizable is indicated for use in Straumann P.004 NC Bone Level implants to protect the inner configuration of the implant and maintains, stabilizes and forms the healing process for us to six months and should be placed out of occlusion. X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {38}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) SYNOCTA ABUTMENTS Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------|--| | <div> <span style="font-family: sans-serif; font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | | | <div> <span style="font-family: sans-serif; font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {39}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems ## Indications for Use (Describe) P.004 ABUTMENTS P.004 TEMPORARY COPINGS P.004 PROTECTIVE CAPS P.004 PERMANENT COPINGS Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns. bridges and overdentures. The subject abutments are for permanent screw-retained bridges and bar-retained implant-borne dentures. Protective Caps are intended to protect the outer configuration of the abutment and condition the contours of the soft tissue during the healing phase for up to 6 months. Copings are intended to serve as a base for multi-unit bar or bridge restorations. Temporary Copings are intended to serve as a base for temporary restorations for up to 6 months. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {40}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Protective Caps are intended to protect the outer configuration of the abutment and condition the contours of the soft tissue during the healing phase for up to 6 months. Temporary Copings are intended to serve as a base for temporary restorations for less than 30 days. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {41}------------------------------------------------ 510(k) Number (if known) K190662 #### Device Name MRI Compatibility for Existing Straumann Dental Implant Systems ### Indications for Use (Describe) P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges and overdentures. The P.004 NC CARES Titanium Abutment is indicated for cemented restoration. The abutment can be used in single tooth replacements and multiple tooth restorations. The P.004 NC CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw retained. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {42}------------------------------------------------ 510(k) Number (if known) K190662 Device Name MRI Compatibility for Existing Straumann Dental Implant Systems ### Indications for Use (Describe) CONCAVE RN HEALING CAP Healing Caps are intended for placement onto dental implants to protect the inner configuration and shoulder of the implant and to maintain, stabilize and form the soft tissue during the healing phase. | Type of Use (Select one or both, as applicable) | |--------------------------------------------------------------------------------------| | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {43}------------------------------------------------ 510(k) Number (if known) K190662 #### Device Name MRI Compatibility for Existing Straumann Dental Implant Systems #### Indications for Use (Describe) STRAUMANN DENTAL IMPLANT SYSTEM Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following: extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Specific indications for small diameter (0 3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------|----------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <di…
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