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Zimmer® One-Piece 4.7mm, Straight implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of partially edentulous jaws. Zimmer® One-Piece 4.7mm, Straight implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. The Zimmer® One-Piece 4.7mm, Straight implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.

The Zimmer One-Piece Implant, 4.7mm, Straight is a one-piece endosseous dental implant which is a combination of implant and abut pent sections. The implant is composed of titanium alloy. The abutment portion is pre-prepared and contoured for esthetic restoration. The abutment portion of the implant features a pre-prepared margin to facilitate the restoration process. The implant section is designed for ease of implantation and with greater surface are for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with double-lead threads.

This document does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested. The document is a 510(k) premarket notification for a Zimmer® One-Piece Implant, 4.7mm, Straight. It describes the device, its intended use, and its substantial equivalence to predicate devices based on mechanical testing, but it does not provide:

1. A table of specific acceptance criteria and reported device performance.
2. Details on sample size for a test set or data provenance (country, retrospective/prospective).
3. Information about experts used for ground truth or their qualifications.
4. Adjudication methods.
5. A multi-reader multi-case (MRMC) comparative effectiveness study, effect size, or human improvement with AI assistance.
6. Standalone algorithm performance without human-in-the-loop.
7. The type of ground truth used (expert consensus, pathology, outcome data).
8. The sample size for a training set.
9. How ground truth for a training set was established.

This document focuses on regulatory approval based on substantial equivalence, primarily supported by mechanical testing mentioned in section 6, "Device Comparison," not on a clinical or performance study with the specifics requested.

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