(211 days)
Inclusive® Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained prosthetic restorations.
All digitally designed abutments for use with Inclusive® Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.
Inclusive® Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained prosthetic restorations.
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Inclusive® Abutments." It confirms the device's substantial equivalence to predicate devices and outlines regulatory requirements.
However, this document does not contain information about acceptance criteria for device performance or any study data that proves the device meets such criteria. It is a regulatory approval letter, not a clinical or performance study report.
Therefore, I cannot provide the requested information based on the input given.
§ 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.)