(245 days)
Abutments:
PREMIUM-SHELTA Conico Abutments are intended to be used in conjunction with a PREMIUM-SHELTA Implants Systems in fully edentulous or partially edentulous maxillary and/or mandibular arches.
The PREMIUM-SHELTA Conico Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit the abutment screw is intended to secure the abutment to the endosseous implant.
PREMIUM-SHELTA Conico Abutments are compatible with PREMIUM-SHELTA Implants Systems. Anchorage of dentures retained by taper friction and supported by PREMIUM-SHELTA Implants Systems.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental prosthetic component. It confirms that the device, "Premium Shelta Prosthetic Components," is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The letter is a regulatory approval, not a technical report on performance validation.
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.)