(182 days)
TDS Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
TDS Abutments are custom titanium or ceramic abutments designed to be used in conjunction with specific dental implants utilizing the screw provided by the implant manufacturer. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Abutments made of titanium are available for Nobel Biocare Replace® RP (Ø 4.3 mm) implants. TDS Abutments made of ceramic are available for Nobel Biocare Replace® WP (Ø 5.0 mm) implants and BioHorizons Internal 4.0 (Ø 4.5 mm platform) implants.
This document is a 510(k) premarket notification for a dental device, the TDS Abutment. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device) and does not require premarket approval (PMA). The key aspect of a 510(k) submission is establishing substantial equivalence to an existing predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies.
Therefore, I cannot provide the requested information from this document because it is not present in the provided text. The document focuses on administrative information, device description, and the FDA's clearance decision based on substantial equivalence.
§ 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.)