Search Results

Zimmer® One-Piece 3.7mm 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 3.7mm implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. The Zimmer® 3.7mm One-Piece implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.

Zimmer® One-Piece 3.0mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. The Zimmer® One-Piece 3.0mm implant must be splinted if two or more are used adjacent to each other. The Zimmer® One-Piece 3.0mm implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.

The Zimmer® Dental One-Piece Implant is a one-piece endosseous dental implant which is a combination of implant and abutment 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 area for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with either double or triple-lead threads, depending upon the apical diameter

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document describes a 510(k) premarket notification for a dental implant system (Zimmer® One-Piece Implant System), detailing its classification, intended use, device description, and comparison to predicate devices, and confirmation of substantial equivalence by the FDA. There is no mention of specific performance metrics, acceptance criteria, or any associated studies with sample sizes, ground truth establishment, or expert involvement to demonstrate the device's performance against defined criteria.

Ask a specific question about this device