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The UTA is intended for use to fabricate and support provisional restorations that aid in creating proper emergence profiles and support gingival architecture throughout the healing phase. It is for use in single tooth restorations in the maxilla or mandible, with non occlussal loading. The UTA can be used for up to one hundred eighty days (180) intra orally.

The UTA is compatible with AstraTech 3.5/4.0 & 4.5/5.0, Biohorizons 3.2/4.5/6, Biomet 3.4, 4.1 & 5, Nobel Biocare Branemark, Nobel Biocare Active Internal RP(4.1/5)&NP(3.5), Nobel Biocare Select NP(3.5)& RP/WP(4.3/5), Nobel Biocare Replace 4.3, Straumann Bone Level NC &RC (4), and Zimmer 3.75, 4.5 &6.

UHA are placed on top of implants to protect the inner components of the implants throughout the healing phase. UHA creates support for gingival architecture and can be used with cement-retained temporary prostheses. It should be placed in non occlusal loading. It can be used for up to 180 days.

The UHA is compatible with AstraTech 3.5/4.0 & 4.5/5.0, Biohorizons 3.2/4.5/6, Biomet 3.4, 4.1 & 5, Nobel Biocare Branemark, Nobel Biocare Active Internal RP(4.1/5)&NP(3.5), Nobel Biocare Select NP(3.5)& RP/WP(4.3/5), Nobel Biocare Replace 4.3, Straumann Bone Level NC &RC (4), and Zimmer 3.75, 4.5 &6.

UHA is a healing abutment which is a PEEK screw-retained post. UTA is a screwretained temporary abutment which is a PEEK post with a predefined apex so a preformed tooth can be attached. Screws are available for Astra Tech 3.5/4.0 &4.5/5.0, Biohorizon 3.2/4.5/6.0, Biomet 3.4/4.0/5.0, Nobel Biocare Branemark, Nobel Biocare Active Internal 4.1/5.0(RP/WP) & 3.5(NP), Nobel Biocare Select 4.3/5.0(RP/WP) & 3.5(NP), Nobel Biocare Replace 4.3, Straumann Bone Level 4.0 NC &RC, Zimmer 3.75/4.5/6.0.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample sizes used for the test sets in the static and fatigue testing. It generally refers to testing "with Astra Tech in both screw sizes," "Biomet 3i in both sizes," "Nobel Select 3.5," and "Nobel Biocare Branemark." This suggests that multiple abutments for various implant systems were tested, but specific numbers are not provided.

The data provenance is not explicitly stated, but based on the context of a 510(k) submission to the FDA, it is highly likely that these were prospective laboratory studies conducted specifically for this submission. The country of origin is not mentioned, but the submitting company is based in Dayton, Ohio, USA, suggesting the testing was likely conducted in the USA or by labs commissioned by the US-based company.

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

This information is not applicable as the evaluation involved physical testing (static and fatigue) of medical devices, not an assessment of data where expert ground truth would typically be established (e.g., image interpretation). The "ground truth" in this context is determined by the physical properties and performance of the devices under specified test conditions.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. Adjudication methods are typically relevant for human-involved assessments (e.g., expert consensus on medical images).

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as the evaluation involved physical testing of medical devices, not human interpretation of medical cases.

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

This information is not applicable. The device is a physical medical implant (temporary abutment), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant here.

7. Type of Ground Truth Used

The "ground truth" was established through physical testing and engineering standards. Specifically:

• Static Strength: The ultimate force or load the abutment could withstand before failure.
• Fatigue Life: The number of cycles the abutment could endure under a specified load before failure.
• Material Composition: Verified through material analysis to confirm PEEK.

The comparison was made against the performance of legally marketed predicate devices under the same test conditions.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical implant, not an AI model or software that requires a training set.

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

This information is not applicable for the reasons stated above.

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