Who is the manufacturer of Straumann Mini Implants?

Institut Straumann AG filed the 510(k) submission for Straumann Mini Implants (K191895).

What is the FDA product code for Straumann Mini Implants?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Straumann Mini Implants?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Straumann Mini Implants?

IMTEC Sendax MDI and MDI Plus (K031106).

Who can help prepare an FDA 510(k) submission like Straumann Mini Implants?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Straumann Mini Implants

K191895 · Institut Straumann AG · DZE · Dec 9, 2019 · Dental

Device Facts

Record ID	K191895
Device Name	Straumann Mini Implants
Applicant	Institut Straumann AG
Product Code	DZE · Dental
Decision Date	Dec 9, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Straumann® Mini Implants ø2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. Strauman® Mini Implants are intended for the stabilization of removable dentures.

Device Story

Straumann Mini Implants are tapered, endosseous dental implants (2.4 mm diameter; 10-14 mm lengths) used to stabilize removable dentures. Manufactured from Roxolid material with an SLA surface, the implants feature an integrated Optiloc attachment element coated in Titanium Nitride (TiN) for denture retention. Used in dental clinics by clinicians, the device is surgically implanted into the jawbone. The Optiloc element provides a mechanical snap-fit connection for removable dentures. By providing a stable anchor, the implants restore chewing function and improve denture stability for edentulous or partially edentulous patients. The device is provided sterile for single use.

Clinical Evidence

Bench testing only. Testing included insertion torque measurements, wear testing of the Optiloc attachment retention properties, and dynamic fatigue testing per ISO 14801. Biocompatibility was established via predicate reference. Sterilization validation was performed per ISO 11137-1/2. Shelf life was validated via real-time and accelerated aging (ASTM F 1980). Endotoxin levels were verified via LAL analysis.

Technological Characteristics

Material: Roxolid; Surface: SLA; Attachment coating: Titanium Nitride (TiN). Dimensions: 2.4 mm diameter, 10-14 mm lengths. Principle: Endosseous dental implant with mechanical retention (Optiloc). Sterilization: Gamma irradiation (SAL 10^-6). Standards: ISO 14801 (fatigue), ISO 11137 (sterilization), ASTM F 1980 (aging).

Indications for Use

Indicated for fully or partially edentulous patients requiring oral endosteal implantation in the upper or lower jaw for the stabilization of removable dentures; suitable for immediate function when primary stability is achieved.

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

IMTEC Sendax MDI and MDI Plus (K031106)

Reference Devices

Straumann Dental Implant System (K083550)
Straumann BLX Line Extension New Abutments (K190040)
MRI Compatibility for Existing Straumann Dental Implant Systems (K190662)

Related Devices

K200906 — MINICONE Implant · Medentika GmbH · Oct 16, 2020
K211052 — Straumann RidgeFit Implants · Institut Straumann AG · Jul 8, 2021
K250294 — Straumann® RidgeFit Implants · Institut Straumann AG · Aug 12, 2025
K092594 — ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX · Ace Surgical Supply Co., Inc. · Sep 16, 2009
K202942 — Straumann 4 mm Short Implants · Straumann USA, LLC · Feb 8, 2021

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. December 9, 2019 Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801 Re: K191895 Trade/Device Name: Straumann® Mini Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: September 9, 2019 Received: September 10, 2019 Dear Jennifer Jackson: 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 (OS) 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. 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K191895 Device Name : Straumann® Mini Implants Indications for Use (Describe) Straumann® Mini Implants ø2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. Strauman® Mini Implants are intended for the stabilization of removable dentures. Type of Use (Select one or both, as applicable) 図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 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}------------------------------------------------ ## Straumann® Mini Implants 510(k) Summary #### 5 510(k) Summary #### 5.1 Submitter's Contact Information | Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, MA 01810 Registration No.: 1222315 Owner/Operator No.: 9005052 | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jennifer M. Jackson, MS Director of Regulatory Affairs and Quality Phone Number : +1-978-747-2509 Fax Number : +1-978-747-0023 E-mail: jennifer.jackson@straumann.com | | Prepared By & Alternate Contact: | Viviana Horhoiu Regulatory Affairs and Compliance Manager Institut Straumann AG Phone number : +41 61 965 1512 | | Date of Submission: | December 9, 2019 | #### 5.2 Name of the Device | Trade Names: | Straumann Mini Implants | |-------------------------|---------------------------| | Common Name: | Endosseous Dental Implant | | Classification Name: | Endosseous Dental Implant | | Regulation Number: | §872.3640 | | Device Classification : | II | | Product Code(s): | DZE | | Proprietary Name: | Straumann Mini Implants | #### 5.3 Predicate Device(s) Primary Predicate: - K031106 IMTEC Sendax MDI and MDI Plus • {4}------------------------------------------------ ### Straumann® Mini Implants 510(k) Summary Reference Devices: - K083550 Straumann Dental Implant System ● - K190040 Straumann BLX Line Extension New Abutments . - K190662 MRI Compatibility for Existing Straumann Dental Implant Systems ● #### 5.4 Device Description The Straumann Mini Implants are tapered implants with an external diameter of 2.4 mm and lengths of 10, 12, and 14 mm. Standard manufacturing processes such machining, surface treatment, cleaning, packaging and sterilization were applied for the subject devices. There are no significant changes related to the implant material, surface treatment, fundamental operating principles, sterilization processes or procedures between the subject devices and the reference devices cleared under K083550. The main difference is the Optiloc® attachment element incorporated on the top of the implant. The implants are manufactured utilizing the Roxolid material and are finished with SLA® surface. The implant neck is machined and the Optiloc® attachment element of the implants is acting as a retention feature for dentures and it is coated using a Titanium Nitride (TiN) coating. Straumann® Mini Implants Ø2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. The Straumann Mini Implants are intended for the stabilization of removable dentures. The removable dentures are connected to the Mini Implants through the incorporated Optiloc® attachment element. #### 5.5 Indications for Use Straumann® Mini Implants Ø2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. Straumann® Mini Implants are intended for the stabilization of removable dentures. {5}------------------------------------------------ ### Straumann® Mini Implants 510(k) Summary #### Technological Characteristics 5.6 The technological characteristics of the subject devices are compared to the primary predicate and reference devices in Table 1. The Indications for Use for the subject devices differs from the primary predicate (K031106) with respect to the indication for inter-radicular transitional applications. The subject devices are not indicated for interradicular transitional applications, however, the remaining indications are equivalent. The reference predicate K190662 is included for reference to all MRI compatibility. The reference predicate K190040 is included for reference to the TiN coating on the Straumann BLX Novaloc Abutments (for clarity only this portion of the cleared Indications for Use Statement for K190040 is included in Table 1). {6}------------------------------------------------ # Straumann® Mini Implants 510(k) Summary | FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K Number | K191895 | K031106 | K083550 | K190040 | | Indications for Use | Straumann® Mini Implants Ø2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. Straumann® Mini Implants are intended for the stabilization of removable dentures. | The MDI and MDI PLUS are self- tapping titanium threaded screws indicated for long-term intra-bony applications. Additionally, the MDI may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full partial edentulism, and employing minimally invasive surgical intervention. | 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 (Ø3.3 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. | Straumann BLX Novaloc Abutments The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants. | | Implant Diameter | 2.4 mm | 2.4 mm | 3.3 mm | The reference device is not an implant | {7}------------------------------------------------ # Straumann® Mini Implants 510(k) Summary | FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | |-------------------------------------------|-------------------------------------|-------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------| | K Number | K191895 | K031106 | K083550 | K190040 | | Implant Length | 10, 12, 14 mm | 10, 13, 15, 18 mm | 8, 10, 12, 14, 16 mm | The reference device is not an implant | | Material | Roxolid | Ti-6Al-4V | Roxolid | Ti-6Al-4V | | Coating | TiN coated | No coating | No coating | TiN coated | | Surface Treatment | SLA | Not available | SLA | Partially anodized | | Abutment-to- restoration connection | Anchor ball | O-Ball | Screw retained | Snap-on feature | | Type of recommended restoration | Stabilization of removable dentures | Stabilization of removable dentures | Support for prosthetic devices, crowns, bridges and overdentures | Attachment of full or partial dentures on dental implants | | Sterilization Method | Gamma irradiation | No information available | Gamma irradiation | Not provided sterile | Table 1 – Comparison of subject device versus predicate/reference devices {8}------------------------------------------------ ### Straumann® Mini Implants 510(k) Summary #### 5.7 Performance Testing Insertion torque testing and wear testing were conducted according to the FDA quidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the Straumann Mini Implants are equivalent to the predicate and reference devices. The purpose of the insertion torque test is to check that the Straumann Mini Implants and the related cutting instruments make it possible to reach a suitable implant insertion torque. The average value of insertion torque measurements for each bone plate density and each implant length are within the define acceptance criteria. Wear testing is performed to evaluate the performance of the Optiloc® attachment with regard to its retention properties. The retention force loss of the Optiloc® blue ring on Straumann Mini Implants passed the acceptance criteria. No new issues of biocompatibility are raised for the subject devices. The Roxolid material was previously cleared per K083550 and the TiN coating was previously cleared per K190040. The sterilization process for the Straumann Mini Implants as recommended in the labeling was validated in accordance with ISO 11137-1:2006, Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05. The subject devices are sterilized via gamma irradiation at a dose of 25 kilogray (2.5 Mrad) Minimum and will be sterilized after packaging. A sterility assurance level (SAL) of 10-6 had been validated according to the standard cited above. The validation method used was the over kill bioburden method in accordance with ISO 11137-2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose. The subject devices are single use and are provided sterile. The shelf life is five years. Shelf life determination has been conducted in real time and accelerated (according to ASTM F 1980 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices) samples. The subject devices will not be marketed as non-pyrogenic. The method used to make the determination that the device meets pyrogen limit specifications is LAL Endotoxin Analysis. The testing limit is 20 EU/device. {9}------------------------------------------------ ## Straumann® Mini Implants 510(k) Summary Dynamic fatigue testing was conducted according to ISO 14801, Dentistry – Implants – Dynamic fatigue test for endosseous dental implants and to the FDA Guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". The tests were conducted in ambient air at room temperature and demonstrated the Straumann Mini Implants are equivalent to the primary predicate devices. #### 5.8 Conclusion The documentation submitted in this premarket notification demonstrates the Straumann Mini Implants are substantially equivalent to the primary predicate and reference devices.