OmniTaper EV Dental Implants, DS Implants abutments with EV connection

K221094 · Dentsply Sirona · DZE · Nov 16, 2022 · Dental

Device Facts

Record IDK221094
Device NameOmniTaper EV Dental Implants, DS Implants abutments with EV connection
ApplicantDentsply Sirona
Product CodeDZE · Dental
Decision DateNov 16, 2022
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended Use

The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: - Replacing missing teeth in single or multiple unit applications in the mandible or maxilla. - Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge. - Especially indicated for use in soft bone applications with other implant surface treatments may be less effective. - Immediate and early loading for all indications, except in single tooth situations on implants shorter than 8 mm or in soft bone (type 4) where implant stability may be difficult to obtain and immediate loading may not be appropriate. - The intended use for OmniTaper EV Ø3.0 implant is limited to replacement of maxillary lateral incisors and mandibular incisors. DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.

Device Story

OmniTaper EV Dental Implants and DS Implants abutments are root-form endosseous dental implants and prosthetic components; used by dental clinicians for prosthetic rehabilitation of edentulous/partially edentulous jaws. Implants are placed surgically into the jawbone; abutments connect to implants via EV connection to support crowns, bridges, or overdentures. Input: surgical site preparation; Output: stable prosthetic foundation. Used in dental clinics. Benefits: restoration of chewing function. Device includes various abutment types (TempBase, TiDesign, MultiBase, etc.) and accessories. MRI conditional status applies to implants/abutments; TempBase Cap is MR safe.

Clinical Evidence

No new human clinical studies performed. Substantial equivalence supported by bench testing (fatigue, biocompatibility, sterilization, MRI) and literature review of reference device Xive S Plus D 3.0 (K073075). Four peer-reviewed studies (1-4 year follow-up, >580 implants) reported >99% survival rates and stable marginal bone, confirming clinical reliability for narrow 3.0mm implants.

Technological Characteristics

Materials: Commercially pure titanium (Grade 4, ASTM F67-13), titanium alloy, gold alloy, PEEK, plastic. Design: Root-form, cylindrical, threaded, self-tapping apical thread, conical EV connection. Sterilization: E-beam irradiation (sterile components) or steam sterilization (non-sterile components). Connectivity: Mechanical connection (EV).

Indications for Use

Indicated for patients requiring dental restoration in mandible or maxilla; includes single/multiple tooth replacement, immediate placement in extraction sites, and soft bone applications. Contraindicated for immediate loading in single tooth sites with implants <8mm or soft bone (type 4). Ø3.0 implant limited to maxillary lateral and mandibular incisors.

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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Dentsply Sirona Courtney Clark Senior Director of Regulatory Affairs, Corporate 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401 Re: K221094 Trade/Device Name: OmniTaper EV Dental Implants, DS Implants abutments with EV connection Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 20, 2022 Received: October 20, 2022 Dear Courtney Clark: 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. # Andrew I. Steen -S Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K221094 Device Name OmniTaper EV Dental Implants #### Indications for Use (Describe) The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: - · Replacing missing teeth in single or multiple unit applications in the mandible or maxilla. - · Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge. - · Especially indicated for use in soft bone applications with other implant surface treatments may be less effective. · Immediate and early loading for all indications, except in single tooth situations on implants shorter than 8 mm or in soft bone (type 4) where implant stability may be difficult to obtain and immediate loading may not be appropriate. · The intended use for OmniTaper EV Ø3.0 implant is limited to replacement of maxillary lateral incisors and mandibular incisors. | 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 "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K221094 Device Name DS Implants abutments with EV Connection Indications for Use (Describe) DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|-----------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☑</span> | | 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 "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K221094 Device Name DS Implants abutments with EV Connection Indications for Use (Describe) MultiBase Abutments EV: DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures. Type of Use (Select one or both, as applicable) | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------------------| | <span style="font-family: DejaVu Sans, sans-serif">☐</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 "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ #### 510(k) SUMMARY for K221094 - OmniTaper EV Dental Implants and Abutments - 1. Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 Contact Person: Courtney Clark Telephone Number: 248-895-4379 Fax number: 717-849-4343 Date Prepared: November 10, 2022 - 2. Device Name: | • | Proprietary Name: | OmniTaper EV Dental Implants,<br>DS Implants abutments with EV connection | |---|------------------------|---------------------------------------------------------------------------| | • | Classification Name: | Implant, Endosseous, Root-form<br>Abutment, Implant, Dental Endosseous | | • | Classification Number: | 872.3640 | | • | Device Class: | Class II | | • | Product Codes: | Primary product code: DZE<br>Secondary product code: NHA | #### 3. Predicate and Reference Devices: The proposed devices in this bundled 510(k) include bundles (A) and (B): - (A) OmniTaper EV Dental Implants, and - (B) DS Implants abutments with EV Connection There are two predicate devices identified relating to the substantial equivalence for the proposed devices (A) and (B), as referred to above as bundles (A) and (B): | Predicate Device (A) Name | 510(k) | Company Name | |---------------------------|---------|----------------------------------------------| | OsseoSpeed Plus Implants* | K120414 | Dentsply Sirona<br>(Formerly: Astra Tech AB) | | Predicate Device (B) Name | 510(k) | Company Name | *NOTE: The OsseoSpeed Plus K120414 clearance included the Astra Tech OsseoSpeed Plus Implants, which are currently marketed as Astra Tech OsseoSpeed EV Implants, and Astra Tech Implant System Plus abutments, which are currently marketed as Astra Tech Implant EV abutments. Therefore, this submission will hereafter refer to the implants cleared under OsseoSpeed Plus (K120414) as predicate {6}------------------------------------------------ (A) Astra Tech EV Implants (K120414) and the abutments cleared under the same 510(k) as compatible Astra Tech EV Abutments (K120414) In addition, four reference devices are identified to support any differences in technological characteristics: | Reference Device Name | 510(k) | Company Name | |------------------------------------------------|---------|-------------------------------------------------------| | Xive S Plus Dental Implant<br>System | K073075 | Dentsply Sirona<br>(formerly: Dentsply International) | | PrimeTaper EV Dental Implant<br>System | K210610 | Dentsply Sirona | | Xive Dental Implant System | | | | Friadent TempBase EV Abutment<br>(Ø3.5 - Ø5.5) | K013867 | Dentsply Sirona<br>(formerly: Friadent GmbH) | | Xive 3.0 Dental Implant System | | | | Friadent TempBase EV Abutment<br>(Ø3.0) | K030639 | Dentsply Sirona<br>(formerly: Friadent GmbH) | #### 4. Description of Device: The proposed (A) OmniTaper EV Dental Implants are root form endosseous implants intended for use by a dental clinician in the prosthetic restoration of chewing function in edentulous human jaws. The proposed (A) OmniTaper EV Dental Implants have the identical implant-abutment connection geometry as predicate (A) Astra Tech EV Implants (K120414). The proposed (A) OmniTaper EV Dental Implants are therefore compatible with the Astra Tech EV Abutments (K120414). The proposed (B) DS Implant abutments with EV connection include the following abutments and accessories: - TempBase EV, and its accessory component TempBase Cap ● - Cover Screw EV ● - Healing Abutment EV ● - HealDesign EV ● - TempAbutment EV - TiDesign EV ● - CastDesign EV ● - MultiBase Abutment EV ● - Abutment Screw EV ● The proposed (B) DS Implants abutments with EV connection are used in conjunction with an endosseous dental implant with EV connection to aid in prosthetic rehabilitation in fully edentulous or partially edentulous maxillary and/or mandibular arches. They are prosthetic abutments that are: - Compatible with the proposed (A) OmniTaper EV implants, ● - Represent an additional abutment type (TempBase EV abutment and cap), {7}------------------------------------------------ - Introduce additional abutment sizes (XS Extra Small and XL Extra Large) to . the predicate (B) DS Implants abutments with EV Connection in sizes S (Small), M (Medium) and L (Large) (K213449). The proposed (B) DS Implant abutments with EV connection have the identical implantabutment connection geometry as predicate (B) DS Implants abutments with EV connection (K213449) and the Astra Tech EV Abutments (K120414), and are therefore also compatible with predicate (A) Astra Tech EV Implants (K120414). The proposed (A) OmniTaper EV Dental Implants and proposed (B) DS Implants abutments with EV connection are single-use devices. The proposed (A) OmniTaper EV implant with pre-mounted proposed (B) TempBase EV abutment, and the proposed (B) devices Cover Screw EV, Healing Abutment EV, HealDesign EV and (B) Multibase Abutment EV are provided sterile via Electronic-Beam (E-beam) irradiation. The proposed (B) TiDesign EV, CastDesign EV, TempAbutment EV, TempBase Cap and Abutment Screw are provided non-sterile. Devices provided non-sterile are to be sterilized via steam sterilization, or as in the case of the TempBase Cap, cleaned/disinfected, by the end user prior to use per the Instructions for Use. Risk analysis for the proposed devices was conducted in accordance with ISO 14971:2019, "Medical Devices: Application of Risk management to medical devices". Risks listed in the FDA guidance document "Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments Class II Special Controls Guidance Document Guidance for Industry and FDA Staff" were addressed and all risks associated with the proposed implants and abutments were acceptable and as low as possible. ## 5. Indications for Use: The Indications for Use for the proposed (A) OmniTaper EV Dental Implants are: The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: - Replacing missing teeth in single or multiple unit applications in the mandible or . maxilla. - Immediate placement in extraction sites and in situations with a partially or . completely healed alveolar ridge. - Especially indicated for use in soft bone applications where implants with other . implant surface treatments may be less effective. - Immediate and early loading for all indications, except in single tooth situations on . implants shorter than 8 mm or in soft bone (type 4) where implant stability may be difficult to obtain, and immediate loading may not be appropriate. - The intended use for OmniTaper EV Ø3.0 implant is limited to replacement of . maxillary lateral incisors and mandibular incisors. All proposed (B) DS Implants abutments with EV connection, with the exception of the MultiBase Abutment EV, fall under the first indications for Use statement below. The second Indications for Use statement applies to the proposed (B) MultiBase Abutment EV. {8}------------------------------------------------ ### DS Implants abutments with EV connection: DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. ## MultiBase Abutments EV: DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures. ## 6. Comparison of Technological Characteristics: The proposed (A) OmniTaper EV implants are a new line of endosseous dental implants which are identical with regards to material, surface treatment and internal implantabutment connection geometry (i.e. the EV connection) as the predicate (A) Astra Tech EV Implants (K120414). The implant dimensions and outer implant design with thread design properties, thread pitch, self-tapping apical thread, condensing upper section and microextended implant shoulder of the proposed (A) OmniTaper EV implants are the same or very similar to reference device Xive S Plus implants (K073075). The proposed (A) OmniTaper EV implant also shares the same packaging as the reference device (K073075). The proposed (B) DS Implants abutments with EV connection are based on the design of the predicate (B) DS Implants Abutments (K213449). It is a line extension of the assortment of compatible EV abutments by: - . adding an abutment type (TempBase EV abutment and Cap) and - adding abutment sizes (XS Extra Small and XL Extra Large) to the predicate (B) DS . Implants abutments with EV Connection (K213449). The design of the proposed (B) TempBase EV abutment is similar to reference device Friadent TempBase Abutments (K030639, K013867) in that the proposed (B) TempBase EV abutment has an EV connection, while the reference device Friadent TempBase Abutments (K030639, K013867) are designed for a hexagonal implant connection. The proposed (B) TempBase EV is pre-mounted on the proposed (A) OmniTaper EV Implant and are packaged together in very similar packaging as reference device Xive S Plus implant (K073075). The proposed (B) accessory component TempBase Cap has identical design and material as reference device Friadent TempBase Cap (K013867) and is cleaned and disinfected in the same way. The proposed (B) DS Implants abutments with EV connection (XS, XL) and predicate (B) DS Implants abutments with EV connection (K213449) have the same intended use, same Indications for Use, same materials, same design (one-piece or two-piece), same prosthesis attachment method (screw-retained or cement-retained), same manufacturing, same packaging (sterile and non-sterile) and same sterilization method as the predicate (B) abutments (K213449). An overview of the similarities and differences between the proposed devices (A) and (B) and predicate (A) and (B) devices, including reference devices, are given in Table 1 through Table 4 below. {9}------------------------------------------------ | Item | Proposed device (A) | Predicate device (A) | Comparison Discussion | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Dentsply Sirona | Dentsply Sirona | | | | OmniTaper EV Dental Implants | Astra Tech EV Implants (K120414) | | | Indications for Use | The implants are intended for both one- and two-<br>stage surgical procedures in the following<br>situations and with the following clinical<br>protocols:<br>Replacing missing teeth in single or<br>multiple unit applications in the mandible<br>or maxilla. Immediate placement in extraction sites<br>and in situations with a partially or<br>completely healed alveolar ridge. Especially indicated for use in soft bone<br>applications where implants with other<br>implant surface treatments may be less<br>effective. Immediate and early loading for all<br>indications, except in single tooth<br>situations on implants shorter than 8 mm<br>or in soft bone (type 4) where implant<br>stability may be difficult to obtain, and<br>immediate loading may not be<br>appropriate. The intended use for OmniTaper EV Ø3.0<br>implant is limited to replacement of<br>maxillary lateral incisors and mandibular<br>incisors. | The Astra Tech Dental Implants are intended for<br>both one- and two-stage surgical procedures in the<br>following situations and with the following clinical<br>protocols:<br>Replacing single and multiple missing<br>teeth in the mandible and maxilla, Immediate placement in extraction sites<br>and in situations with a partially or<br>completely healed alveolar ridge, Especially indicated for use in soft bone<br>applications where implants with other<br>implant surface treatments may be less<br>effective, Immediate loading in all indications,<br>except in single tooth situations on<br>implant shorter than 8 mm or in soft bone<br>(type IV) where implant stability may be<br>difficult to obtain and immediate loading<br>may not be appropriate. The intended use for OsseoSpeed Plus 3.0<br>S is limited to replacement of maxillary<br>lateral incisors and mandibular incisors. | The Indications for Use of the proposed and<br>predicate implants are similar.<br><br>The indications of the proposed and predicate<br>device have slight differences in wording, for<br>clarification only.<br><br>For the proposed (A) device, "early loading" was<br>added to describe the loading protocol of the<br>implant in more detail.<br><br>The differences in the proposed and predicate<br>Indications for Use do not substantively alter the<br>meaning. | # Table 1: Similarities and Differences between the Proposed (A) and Predicate (A) Dental Implants Indications for Use {10}------------------------------------------------ # Table 2: Similarities and Differences between the Proposed devices (A), and Reference Device Device Dental Implants Technological Characteristics | Item | Proposed devices (A) | Predicate devices (A) | Reference devices | Comparison Discussion | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Technological Characteristics | | | | | | Dentsply Sirona<br>OmniTaper EV Dental Implants | Dentsply Sirona<br>AstraTech EV Dental Implants<br>(K120414) | Dentsply Sirona<br>Xive S Plus implants<br>(K073075) | | | Implant<br>material | Commercially pure titanium (Grade 4)<br>(ASTM F67-13 (2017)) | Commercially pure titanium (Grade 4)<br>(ASTM F67-13 (2017)) | Commercially pure titanium (Grade 2)<br>(ASTM F67-13 (2017)) | Same as predicate device (A) (K120414). | | Surface<br>treatment | TiO2 blasted and acid etched | TiO2 blasted and acid etched | Grit blasted and acid etched | Same as predicate device (A) (K120414). | | Connection<br>type | Conical connection with indexes (EV<br>Connection) | Conical connection with indexes (EV<br>Connection) | Internal hexagonal connection | Same as predicate device (A) (K120414). | | Implant<br>design | Cylindrical, threaded, self-tapping<br>apical thread | Cylindrical, threaded | Cylindrical, threaded, self-tapping<br>apical thread | Same as reference device (K073075). | | Neck design | (Micro)extended implant shoulder | Cylindrical with micro-threads | (Micro)extended implant shoulder | Same as reference device (K073075). | | Type of<br>implantation | Bone level implant | Bone level implant | Bone level implant | Same. | | Sites in body | Mandible/maxilla | Mandible/maxilla | Mandible/maxilla | Same. | | Implant<br>diameter and<br>length | Ø 3.0 diameter implant: Limited to<br>maxillary lateral incisors and<br>mandibular incisors<br>Ø 3.0 x L 11, 13 and 15 mm<br>Ø 3.4 x L 9.5, 11, 13, 15 and 18 mm<br>Ø 3.8 x L 8, 9.5, 11, 13, 15 and 18 mm<br>Ø 4.5 x L 8, 9.5, 11, 13, 15 and 18 mm<br>Ø 5.5 x L 8, 9.5, 11, 13 and 15 mm | Ø 3.0 diameter implant: Limited to<br>maxillary lateral incisors and<br>mandibular incisors<br>Ø 3.0 x L 8, 9, 11, 13 and 15 mm<br>Ø 3.6 x L 6, 8, 9, 11, 13, 15 and 17 mm<br>Ø 4.2 x L 6, 8, 9, 11, 13, 15 and 17 mm<br>Ø 4.8 x L 6, 8, 9, 11, 13, 15 and 17 mm<br>Ø 5.4 x L 6, 8, 9, 11, 13 and 15 mm | Ø 3.0 diameter implant: Limited to<br>maxillary lateral incisors and<br>mandibular incisors<br>Ø 3.0 x L 11, 13 and 15 mm<br>Ø 3.4 x L 9.5, 11, 13, 15 and 18 mm<br>Ø 3.8 x L 8, 9.5, 11, 13, 15 and 18 mm<br>Ø 4.5 x L 8, 9.5, 11, 13, 15 and 18 mm<br>Ø 5.5 x L 8, 9.5, 11, 13 and 15 mm | Same as reference device (K073075) with<br>minor modification to the outer geometry<br>thickness of material for 8 mm length<br>implants (Ø 3.8, 4.5, and 5.5) only, which<br>do not represent new worst case implants.<br><br>Substantial equivalence is supported by<br>fatigue testing with similar results compared<br>to predicate device (A) (K120414). | | Item | Proposed devices (A)<br>Dentsply Sirona<br>OmniTaper EV Dental Implants | Predicate devices (A)<br>Dentsply Sirona<br>AstraTech EV Dental Implants<br>(K120414) | Reference devices<br>Dentsply Sirona<br>Xive S Plus implants<br>(K073075) | Comparison Discussion | | Angulation of<br>compatible<br>abutments | XS (Ø3.0): 0°, 15°<br>S – L (Ø3.4-4.5): 0°, 15°, 17°, 20°, 30°<br>XL (Ø5.5): 0°, 15°<br>(Compatible abutments cleared in<br>K120414, K121810, K163350,<br>K111287, K130999, K112138,<br>K213449) | Ø3.0: 0°, 15°<br>Ø3.6-4.8: 0°, 15°, 17°, 20°, 30°<br>Ø5.4: 0°<br>(Compatible abutments cleared in<br>K120414, K121810, K163350,<br>K183079, K111287, K130999,<br>K112138, K213449) | Ø3.0: 0°, 15°<br>Ø3.4-5.5: 0°, 15°, 30°<br>(Compatible abutments cleared in<br>K945847, K980630, K982576,<br>K994174, K994376, K013438,<br>K013867, K030639, K072730,<br>K093780, K122268, K183079) | Proposed (A) device is compatible with<br>abutments within the same range of<br>angulation as the reference implants<br>(K073075).<br>Substantial equivalence is supported by<br>fatigue testing with similar results compared<br>to predicate device (A) (K120414). | | Reusability | Single use | Single use | Single use | Same. | | Sterility state | Sterile | Sterile | Sterile | Same. | | Sterilization<br>method | Electron-beam irradiation | Electron-beam irradiation | Gamma irradiation | Same as predicate device (A) (K120414) | {11}------------------------------------------------ {12}------------------------------------------------ | Item | Proposed device (B) | Predicate device (A) | Comparison Discussion | | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Dentsply Sirona | Dentsply Sirona | | | | | DS Implants Abutments with EV connection | DS Implants Abutments with EV connection<br>(K213449) | | | | Indications for Use | DS Implants abutments with EV connection:<br>DS Implants abutments provided with the EV<br>connection are intended to be used in conjunction<br>with implants with the EV connection in fully<br>edentulous or partially edentulous maxillary and/or<br>mandibular arches to provide support for crowns,<br>bridges or overdentures.<br><br>MultiBase Abutment EV:<br>DS Implants abutments provided with the EV<br>connection are intended to be used in conjunction<br>with implants with the EV connection in fully<br>edentulous or partially edentulous maxillary and/or<br>mandibular arches to provide support for bridges<br>or overdentures. | DS Implants abutments with EV connection:<br>DS Implants abutments provided with the EV<br>connection are intended to be used in conjunction<br>with implants with the EV connection in fully<br>edentulous or partially edentulous maxillary and/or<br>mandibular arches to provide support for crowns,<br>bridges or overdentures.<br><br>MultiBase Abutment EV:<br>DS Implants abutments provided with the EV<br>connection are intended to be used in conjunction<br>with implants with the EV connection in fully<br>edentulous or partially edentulous maxillary and/or<br>mandibular arches to provide support for bridges<br>or overdentures. | Same. | | | Item | Proposed device (B) | Predicate device (A) | Reference devices | Comparison Discussion | | | Dentsply Sirona<br>DS Implants Abutments with EV<br>connection | Dentsply Sirona<br>DS Implants Abutments with<br>EV connection<br>(K213449) | Dentsply Sirona<br>Xive Dental Implant System<br>Abutments and Accessories<br>(K013867, K030639) | | | Connection Size | XS, XL<br>TempBase EV Abutment and Cap:<br>XS, S, M, L, XL | S, M, L | Friadent TempBase Abutment<br>and TempBase Cap:<br>D3.0, D3.4, D3.8, D4.5, D5.5 | Expansion of offering to include XS and<br>XL abutments compatible with proposed<br>(A) device. Addition of TempBase EV<br>abutment and Cap in all sizes.<br>Substantial equivalence supported by<br>fatigue testing. | | Prosthesis<br>attachment | Cement-retained<br>Screw-retained | Cement-retained<br>Screw-retained | TempBase Abutment:<br>Screw-retained | Same | | Abutment<br>angulation | TiDesign EV:<br>0°, 15°<br>MultiBase EV:<br>0°<br>TempBase EV:<br>0°<br>CastDesign EV:<br>0° | TiDesign EV:<br>0°, 15°<br>MultiBase EV:<br>0°, 17°, 30°<br>CastDesign EV:<br>0° | TempBase Abutment:<br>0° | TiDesign EV: Same as predicate device<br>TempBase EV: Same as reference device<br>MultiBase EV: Proposed (B) MultiBase<br>abutments (XS) and (XL) are not<br>available as an angulated abutment.<br>CastDesign EV: Straight abutment, no<br>angular correction. Same as predicate<br>device. | | Abutment<br>design | One-piece (0°),<br>Two-piece (0°,15°) | One-piece (0°),<br>Two-piece (0°,15°) | TempBase Abutment:<br>One-piece (0°) | Same | | Gingiva height | Healing Abutment EV:<br>2, 3, 4, 6 mm<br>HealDesign EV:<br>2.5, 3.5, 4.5, 6.5 mm<br>TiDesign EV: | Healing Abutment EV:<br>2, 3, 4, 6 mm<br>HealDesign EV:<br>2.5, 3.5, 4.5, 6.5 mm<br>TiDesign EV: | Not applicable for substantial<br>equivalence | Same as predicate device. | | Item | Proposed device (B) | Predicate device (A) | Reference devices | Comparison Discussion | | | Dentsply Sirona<br>DS Implants Abutments with EV<br>connection | Dentsply Sirona<br>DS Implants Abutments with<br>EV connection<br>(K213449) | Dentsply Sirona<br>Xive Dental Implant System<br>Abutments and Accessories<br>(K013867, K030639) | | | | 1.5, 2.5, 3.5, 4.5 mm<br>MultiBase Abutment EV:<br>1.5, 2.5, 3.5, 4.5 mm | 1.5, 2.5, 3.5, 4.5 mm<br>MultiBase Abutment EV:<br>1.5, 2.5, 3.5, 4.5 mm…
Innolitics
510(k) Summary
Decision Summary
Classification Order
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