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Straumann Regular Neck and Narrow Neck implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.

The Straumann Regular Neck Implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients for single-stage or two-stage surgery.

The Straumann Narrow Neck implants are intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the Narrow Neck implant is indicated for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited (minimum 5 mm) and where vestibule-oral bone is restricted (minimum 5 mm). The Narrow Neck implant can also be used as a support for a full arch implant-born restoration, but only in conjunction with a standard Straumann 4. 1 mm dental implant.

The Straumann Dental Implant with anodized neck is a minor modification of cleared Straumann Dental Implants. The implants with anodized neck are available in two neck sizes, RN diameter 4.8 mm and NN diameter 3.5 mm. The design of the modified implants is identical to the predicate implants. There is no change to the endosseous grit blasted, acid etched SLA surface. The subject implants have the same material composition and the same endosseous surface treatment as previously cleared Straumann implants. In addition, the design of the implant is identical to the predicate devices.

This submission does not contain information about acceptance criteria or a study proving that a device meets such criteria. It is a 510(k) summary for Straumann Anodized Neck Implants, focusing on demonstrating substantial equivalence to previously cleared predicate devices. The document highlights that the new device is a minor modification (anodized neck for aesthetic purposes) and shares the same material composition, endosseous surface treatment, and implant design as the predicate devices. Therefore, the requested information cannot be extracted from the provided text.

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