(240 days)
The SwissPlant Dental Implant system consists of two-piece implants for one or two-stage surgical procedures that are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained or overdenture restorations and in terminal or immediate abutment support for fixed bridgework. The SwissPlant dental implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing initial implant stability and appropriate occlusal loading, to restore normal masticatory function.
The SwissPlant Dental implant system consists of implants, abutments, healing components, fixation screws and surgical armamentaria for use in one or twostage placement and restorations.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary and an FDA clearance letter for a dental implant system. It describes the device, its intended use, and its substantial equivalence to a predicate device, but it does not detail any performance studies against specific acceptance criteria.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)