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.

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.

AI/ML Overview

The provided text does not include information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically associated with algorithms or diagnostic tools. Instead, it is a 510(k) summary for a medical device (dental implants) and focuses on demonstrating substantial equivalence to a predicate device.

The "performance testing" described in the document primarily relates to:

Sterilization Validation and Shelf Life: Ensuring the device remains sterile and functional over time.
Biocompatibility Testing: Confirming the materials are safe for use in the human body.
Electromagnetic Compatibility: Indicating the device is MR Conditional.
Bench Testing: Mechanical testing (insertion torque, wear, dynamic fatigue) to ensure structural integrity and function, likely against material and mechanical standards.
Clinical Performance (Reference): A literature review to support a change in "Indications for Use" regarding the number of implants for mandibular and maxillary restorations.

Therefore, many of the requested fields cannot be filled as they pertain to the evaluation of an algorithm's performance, which is not the subject of this document.

However, I can extract the information that is present and note where information is not applicable or not provided.

Here's the breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

Feature/Test	Acceptance Criteria (Implied/Standard)	Reported Device Performance
Sterilization	Sterility Assurance Level (SAL) of 10^-6	Validated in accordance with ISO 11137-1:2006 and ISO 11137-2:2013 (VDmax 25 method)
Shelf Life	(Implied: Maintain sterility and integrity for 5 years)	5 years
Biocompatibility	(Implied: Meet ISO standards for medical device biocompatibility)	No new issues raised; no additional testing required as materials/methods unchanged from predicate.
Electromagnetic Compatibility	(Implied: Safe for MRI environments)	Considered MR Conditional.
Bench Testing (Fatigue)	(Implied: Performance equivalent to predicate device per FDA guidance)	New 4.8 mm gingival height demonstrated equivalent performance to predicate. Other relevant bench testing (insertion torque, wear, dynamic fatigue) performed and provided in K191895 in accordance with FDA guidance.

Study Details (where applicable for a medical device application):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Bench Testing: Not explicitly stated in this summary. It refers back to K191895 for the detailed bench testing, and for the new gingival height, it mentions "a fatigue test" without specifying sample size.
Data Provenance: Not applicable in the context of an algorithm's test set. For physical device testing, it's typically internal lab data or certified external lab data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This information pertains to the evaluation of an algorithm's ability to interpret data, which is not what this document describes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This is for algorithm ground truth establishment.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC study is not mentioned as this is a physical dental implant, not an AI/diagnostic tool. The clinical support cited for the labeling change is a systematic review of existing literature, not a new comparative effectiveness study on the device itself.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For Bench Testing: Ground truth is established through engineering standards, test methods, and comparison to predicate device performance.
For Clinical Support of Indications for Use: The "ground truth" or supporting evidence for the revised Indications for Use (specifying implant numbers) comes from a systematic review of clinical literature (Lemos et al. 2017), which synthesizes existing outcomes data from various clinical studies on mini implants.

8. The sample size for the training set

Not Applicable. This device is not an AI algorithm.

9. How the ground truth for the training set was established

Not Applicable. This device is not an AI algorithm.

Summary

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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.

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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 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

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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)

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Straumann® RidgeFit Implants

510(k) Summary

Submitter's Contact Information

Submitter:	Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory Affairs and QualityPhone Number: +1 978 747-2509Fax Number: +1 978 747-0023
Prepared By &Alternate Contact:	Chanrasmey White, MSRegulatory Affairs SpecialistStraumann, 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 .

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Straumann® RidgeFit Implants

510(k) Summary

Device Description

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

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.

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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 forUse	Straumann® RidgeFit Implants Ø2.4 mm arefor oral endosteal implantation in the upperand/or lower jaw of fully edentulous patients.The implants can be placed with immediatefunction when primary stability is achieved forall implants or with conventional loading ifprimary stability is not achieved for allimplants. Straumann® RidgeFit Implants areintended for the stabilization of removabledentures.· For mandibular restorations, at least 4Straumann® RidgeFit Implants Ø2.4 mmshould be placed.· For maxillary restorations, at least 6Straumann® RidgeFit Implants Ø2.4 mmshould be placed.	Straumann® Mini Implants Ø2.4 mm aresuitable for oral endosteal implantation in theupper and lower jaw of fully or partiallyedentulous patients. The implants can beplaced with immediate function when goodprimary stability is achieved.Straumann® Mini Implants are intended forthe stabilization of removable dentures.
ImplantDiameter	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
SurfaceTreatment	SLA	SLA
Abutment-to-restorationconnection	Anchor Ball	Anchor Ball
Recommendedrestoration	Stabilization of removable dentures	Stabilization of removable dentures
SterilizationMethod	Gamma Irradiation	Gamma Irradiation

Table 1 - Comparison of the Subject and the Primary Predicate Devices

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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

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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.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.