(103 days)
BioHorizons Plastic Temporary Abutments are intended for short-term use of 30 days or less as a base for cemented or screw-retained crown and bridge restoration of dental implants, while esthetically contouring soft tissue.
BioHorizons Plastic Temporary Abutments are medical grade machined polyetheretherketone (PEEK) material, supplied sterile using gamma radiation for use as short-term (30 days or less) restorative dental implant abutments.
I'm sorry, but an acceptance criteria table and details about a study on device performance, including information about sample sizes, expert involvement, and ground truth establishment, are not present in the provided text. The document is a 510(k) summary for a dental device, focusing on its substantial equivalence to predicate devices based on design, material, and intended use, rather than a clinical performance study with defined 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.)