(105 days)
The Locator Implant Anchor Abutment for Endosseous Dental Implants is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.
The Locator Implant Bar Attachment System for Endosseous Dental Implants is appropriate for use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous implants in the mandible or maxilla.
Not Found
The provided document is an FDA 510(k) clearance letter for a dental implant system. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested. The letter confirms substantial equivalence to a predicate device, which is a regulatory pathway, not a detailed clinical study report addressing performance metrics.
Therefore, I cannot provide the requested information based on the given text.
§ 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.)