(101 days)
The CAMLOG Logfit™ Prosthetic System is intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the naxillary and/or mandibular arch.
The CAMLOG Logfit Prosthetic System includes dental implant abutments and screws intended to be used to support cement retained crowns and bridges in conjunction with Camlog dental implants in the maxillary and/or mandibular arch. The system also includes impression caps, analogs and plastic, burn-out copings, (Class I exempt, not a part of this submission), intended to facilitate the preparation of prosthetic restorations.
This document does not contain an acceptance criteria table or a study description of the device's performance. The provided text is a 510(k) summary for the CAMLOG Logfit™ Prosthetic System, which focuses on administrative information, device description, intended use, and equivalence to predicate devices, culminating in the FDA's clearance letter.
Therefore, I cannot provide the requested information.
§ 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.)