Straumann RidgeFit Implants

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July 08, 2021 Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810 ### Re: K211052 Trade/Device Name: Straumann RidgeFit Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: April 8, 2021 Received: April 9, 2021 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. 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Sincerely. for Andrew Steen 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}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K211052 Device Name Straumann® RidgeFit Implants Indications for Use (Describe) Straumann® RidgeFit Implants 02.4 mm are for oral endosteal implantation in the upper and/or lower jaw of fully edentulous patients. The implants can be placed with immediate function when primary stability is achieved for all implants or with conventional loading if primary stability is not achieved for all implants. Straumann® RidgeFit Implants are intended for the stabilization of removable dentures. - For mandibular restorations, at least 4 Straumann® RidgeFit Implants ø2.4 mm should be placed. - For maxillary restorations, at least 6 Straumann® RidgeFit Implants Ø2.4 mm should be placed. ● 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 complete and review the collection of information. 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FORM FDA 3881 (6/20) {3}------------------------------------------------ ## Straumann® RidgeFit Implants 510(k) Summary # 510(k) Summary ### Submitter's Contact Information | Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)<br>60 Minuteman Road<br>Andover, MA 01810<br>Registration No.: 1222315 Owner/Operator No.: 9005052 | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jennifer M. Jackson, MS<br>Director of Regulatory Affairs and Quality<br>Phone Number: +1 978 747-2509<br>Fax Number: +1 978 747-0023 | | Prepared By &<br>Alternate Contact: | Chanrasmey White, MS<br>Regulatory Affairs Specialist<br>Straumann, USA, LLC | | Date of Submission: | July 8, 2021 | ### Name of the Device | Trade Names: | Straumann® RidgeFit Implants | |------------------------|---------------------------------------------| | Common Name: | Endosseous dental implant (21 CFR 872.3640) | | Classification Name: | Endosseous dental implant (21 CFR 872.3640) | | Regulation Number: | §872.3640 | | Device Classification: | II | | Product Code(s): | DZE | | Classification Panel: | Dental | ### Predicate Device(s) Primary Predicate: - K191895 Straumann® Mini Implants . {4}------------------------------------------------ ### Straumann® RidgeFit Implants 510(k) Summary ### Device Description The Straumann® RidgeFit Implants are tapered implants manufactured from Roxolid (TiZr) with a finished SLA surface. The implant neck is machined with an Optiloc® attachment portion resulting in a one-piece implant system acting as a retention feature for dentures, this feature is coated in a Titanium Nitride (TiN) coating. The Straumann® RidgeFit Implants have an external diameter of 2.4 mm and are available in implant lengths 10 mm, 12 mm and 14 mm with a gingival height of 2.8 mm and implant lengths 10 mm and 12 mm for gingival heights 3.8 mm and 4.8 mm. The Straumann® RidgeFit Implants are identical to the Straumann® Mini Implants cleared under K191895 apart from proposed labeling changes. Note for US Markets, Straumann has identified Straumann® Mini Implants as Straumann® RidgeFit Implants to distinguish it from other markets, this change has been documented through Memo to File. The purpose of this traditional 510(k) is to propose labeling changes to the cleared indications and the addition of contraindications to the existing devices cleared under K191895. #### Intended Use The Straumann® RidgeFit Implants are intended for the stabilization of removable dentures. The removable dentures are connected to the RidgeFit Implants through the incorporated Optiloc® attachment element. #### Indications for Use Straumann® RidgeFit Implants Ø2.4 mm are for oral endosteal implantation in the upper and/or lower jaw of fully edentulous patients. The implants can be placed with immediate function when primary stability is achieved for all implants or with conventional loading if primary stability is not achieved for all implants. Straumann® RidgeFit Implants are intended for the stabilization of removable dentures. - For mandibular restorations, at least 4 Straumann® RidgeFit Implants Ø2.4 mm should . be placed. - For maxillary restorations, at least 6 Straumann® RidgeFit Implants ø2.4 mm should be . placed. {5}------------------------------------------------ # Straumann® RidgeFit Implants 510(k) Summary ### Technological Characteristics The Straumann® RidgeFit Implants are identical to the Straumann® Mini Implants cleared under K191895 apart from proposed labeling changes under this submission. The purpose of this traditional 510(k) is to propose changes to the cleared indications and to add additional contraindications to the devices cleared under K191895. The technological characteristics of the subject devices are compared to the primary predicate devices in Table 1. | FEATURE | SUBJECT DEVICES | PRIMARY PREDICATE DEVICES | |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K Number | K211052 | K191895 | | Indications for<br>Use | Straumann® RidgeFit Implants Ø2.4 mm are<br>for oral endosteal implantation in the upper<br>and/or lower jaw of fully edentulous patients.<br>The implants can be placed with immediate<br>function when primary stability is achieved for<br>all implants or with conventional loading if<br>primary stability is not achieved for all<br>implants. Straumann® RidgeFit Implants are<br>intended for the stabilization of removable<br>dentures.<br>· For mandibular restorations, at least 4<br>Straumann® RidgeFit Implants Ø2.4 mm<br>should be placed.<br>· For maxillary restorations, at least 6<br>Straumann® RidgeFit Implants Ø2.4 mm<br>should be placed. | Straumann® Mini Implants Ø2.4 mm are<br>suitable for oral endosteal implantation in the<br>upper and lower jaw of fully or partially<br>edentulous patients. The implants can be<br>placed with immediate function when good<br>primary stability is achieved.<br>Straumann® Mini Implants are intended for<br>the stabilization of removable dentures. | | Implant<br>Diameter | 2.4 mm | 2.4 mm | | Implant Length | 10, 12, 14 mm | 10, 12, 14 mm | | Gingival heights | 2.8 mm | 2.8, 3.8 and 4.8 mm | | Material | Roxolid (TiZr) | Roxolid (TiZr) | | Coating | TiN coated | TiN coated | | Surface<br>Treatment | SLA | SLA | | Abutment-to-<br>restoration<br>connection | Anchor Ball | Anchor Ball | | Recommended<br>restoration | Stabilization of removable dentures | Stabilization of removable dentures | | Sterilization<br>Method | Gamma Irradiation | Gamma Irradiation | Table 1 - Comparison of the Subject and the Primary Predicate Devices {6}------------------------------------------------ ## Straumann® RidgeFit Implants 510(k) Summary ### Performance Testing The following performance data support the substantial equivalence determination. ### Sterilization Validation and Shelf Life The Straumann® RidgeFit Implants are single patient devices, are provided sterile via gamma irradiation at a dose of 25 kilogray (2.5 Mrad) Minimum and will be sterilized after final packaging. A sterility assurance level (SAL) of 10° has been 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. The validation method used was the VDmax 25method in accordance with ISO 11137-2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose. The sterilization validation and shelf life data have been submitted under K191895. The shelf life of the subject RidgeFit Implants is 5 years. Sterilization method and shelf life are identical to the primary predicate devices cleared under K191895. #### Biocompatibility Testing There are no changes to the materials, surface treatments, or manufacturing methods from the currently marketed predicate devices. Therefore, no new issues of biocompatibility are raised for the subject devices and no additional biocompatibility testing was required. #### Electromagnetic Compatibility There are no changes to the materials, surface treatments, or manufacturing methods from the currently marketed predicate devices. Therefore, no new issues of electromagnetic compatibility are raised for the subject devices and they can be considered MR Conditional. #### Performance Testing - Bench The RidgeFit (Mini) Implants with 2.8 mm of gingival height have been cleared under K191895. The gingival heights of 3.8 and 4.8 mm for the lengths 10 and 12mm have been introduced via Memo to File. A fatigue test on the new 4.8 mm gingival height has demonstrated a performance equivalent to the primary predicate device of the K191895. Relevant bench testing, including insertion torque, wear, and dynamic fatigue testing, was performed and provided in K191895 in accordance with the FDA guidance document Guidance {7}------------------------------------------------ ## Straumann® RidgeFit Implants 510(k) Summary for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments, Document issued on: May 12, 2004. This submission only intends to propose changes in the labeling of the devices. The subject devices are identical to the previously cleared devices (primary predicate and Memo to File), therefore, no additional performance testing is required. ### Performance Testing - Clinical The change in the Indications for Use to specifically indicate the RidgeFit (Mini) Implants for a minimum of 4 implants in the mandible and a minimum of 6 implants in the maxilla is supported by a clinical summary article by Lemos et al.1 ### Conclusion The documentation submitted in this premarket notification demonstrates the Straumann® RidgeFit Implants are substantially equivalent to the primary predicate. ¹ Lemos CA, Verri FR, Batista VE, Júnior JF, Mello CC, Pellizzer EP. Complete overdentures retained by mini implants: A systematic review. J Dent. 2017 Feb; 57:4-13. Doi: 10.1016/i,ident.2016.11.009. Epub 2016 Nov 22.