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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 (Ø 3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.

Straumann Narrow Neck CrossFit® (NNC) Gold Abutment for Crowns Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.

Straumann Narrow Neck CrossFit® (NNC) Temporary Abutments

The Straumann NNC Temporary Abutments are indicated for use in Straumann NNC Tissue Level Implants for temporary restorations of single crowns and bridges for up to six months.

Straumann Narrow Neck CrossFit® (NNC) Healing Caps and Closure Screws

Straumann NNC Healing Caps and NNC Closure Screws are intended for use with the Straumann NNC Tissue Level Implant System to protect the inner configuration of the implant. Healing Caps have a secondary function to maintain, stabilize and form the soft tissue during the healing process.

Device Description

The proposed Straumann Narrow Neck Connection CrossFit® (NNC) Ø3.3mm Dental Implant System is a new product to be added to our current Tissue Level implant product portfolio. Straumann currently has a Tissue Level dental implant with a Ø3.5mm prosthetic platform with an external hexagon abutment; the abutment and implant are machined as one piece. The proposed system introduces a Ø3.5mm prosthetic platform with an internal CrossFit connection. The proposed system is an implant with no attached abutment. The abutment is sold separately.

The purpose of this 510(k) Premarket Notification is to introduce:

Narrow Neck CrossFit® (NNC) Ø3.3mm dental implant in 4 lengths; a. 8.0mm, 10.0mm, 12.0mm and 14.0m,
b. Gold abutment for use with the crown,
c. NNC posts for temporary restorations made from Titanium. The posts are to be used for a single crown restoration or bridge,
d. NNC closure screws (0mm and 1.5mm),
e. Healing caps (3.0mm, 4.5mm and 2.0mm),
f. NNC impression post, open tray, and
g. NNC analog.

The body of the proposed implant has a threaded Ø3.3mm implant body design with the SLActive surface of Straumann's TiZr Implant currently cleared under K083550. The material of the proposed implant is Straumann's Titanium Zirconium (TiZr) currently cleared under K083550. This design proposes a narrow Tissue Level implant with an internal connection for smaller interdental spaces.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Straumann Narrow Neck CrossFit® (NNC) Ø3.3mm Dental Implant System:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from testing)	Reported Device Performance
Mechanical Integrity	Fatigue Resistance (as per FDA guidance)	Met pre-determined acceptance criteria. Functions as intended.
Biocompatibility	(Not explicitly stated, but implied by regulatory submission)	(Implied to be met, as no new materials were introduced)
Material Equivalence	(Material is Straumann's Titanium Zirconium (TiZr) currently cleared under K083550)	No changes to materials from already cleared devices.
Functional Equivalence	(Operating principles, sterilization processes, and surgical protocols are the same as cleared devices)	No changes to fundamental operating principles, or sterilization processes or procedures. Placement follows established surgical protocols.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the numerical sample size for the fatigue testing. It refers to "Performance Testing" which included "Fatigue Testing."
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given that this is a premarket notification for a medical device seeking clearance, the testing would generally be laboratory-based/bench testing rather than clinical study data from patients, for this type of performance testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This section is not applicable to the provided information. The "ground truth" for the performance testing (fatigue testing) is based on engineering standards and measurement outputs (e.g., cycles to failure, stress levels) rather than expert interpretation of medical images or conditions.

4. Adjudication Method for the Test Set

This section is not applicable to the provided information. Adjudication methods (like 2+1, 3+1) are typically used in studies where human interpretation of data is involved, such as reading medical images, to resolve discrepancies among experts. The performance testing described is bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. The study described is a performance/bench testing study focused on the mechanical integrity of the dental implant system, not a study evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study was done, but it was for the device's mechanical performance, not for an AI algorithm. The fatigue testing was an evaluation of the device itself (the dental implant system) without human interaction in its operation, demonstrating its mechanical integrity. There is no mention of an AI algorithm in this submission.

7. Type of Ground Truth Used

The ground truth used for the performance testing (fatigue testing) was based on pre-determined engineering standards and measurements as defined by the "FDA guidance document 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.'" This guidance document would outline the methodology and acceptable limits for fatigue testing, establishing the objective ground truth against which the device's performance was measured.

8. Sample Size for the Training Set

This section is not applicable. The submission describes bench testing for a physical medical device. There is no AI algorithm being developed or "trained" in this context.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reasons as point 8.

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