(55 days)
The Nobel Biocare Permanent Centric Post is a support component indicated for use as both an alignment post to center an abutment, and as a seal to prohibit fluids from seeping into the implant interior.
The Nobel Biocare Permanent Centric Post is a component within the endosseous implant system, and is intented for use in permanent restorations in order to restore the chewing function of fully edentulous and/or partially edentulous patients.
Nobel Biocare's Permanent Centric Post is a hollow, accessory component designed to enhance the performance of the implant/abutment system by ensuring proper alignment between an abutment and an endosseous implant, while additionally acting as a seal that prevents fluids from seeping into the implant interior.
The Nobel Biocare Permanent Centric Post does not contact any mucous membranes in the oral cavity because it rests inside the implant/abutment interface. The Centric Post can only be used as part of the implant system, not on its own. It is designed to remain inside the implant/abutment interface for as long as the implant remains in the patient's mouth.
This document is a 510(k) summary for the Nobel Biocare Permanent Centric Post, a dental device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Instead, it describes the device, its indications for use, and its substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory submission, not a scientific study report.
§ 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.)