(80 days)
Nobel Biocare's Procera Abutment System is a set of screw retained preparable abutments which are secured to an endosseous implant and is intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient's chowing function.
The Nobel Biocare Procera® Preparable Abutment System is comprised of a titanium abutment which is secured to the Branemark System® dental implants with a gold abutment screw. This system functions as an anchor to which a single crown can be cemented. When more than one preparable abutment is used, a multi-unit bridge can be cemented to the abutments. The Procera® Preparable Abutment also includes a counter torque device and adaptors, temporary cylinders, impression copings and machine Uni-grip screwdrivers.
This document does not contain information about acceptance criteria or a study that proves a device meets such criteria. It is a 510(k) premarket notification for a dental abutment system.
Here's what the provided text does contain:
- Device Name: Nobel Biocare Procera® Preparable Abutment System
- Manufacturer: Nobel Biocare USA, Inc.
- Predicate Device: TiAdapt Abutments (K971706) and other existing components from Nobel Biocare's Branemark System®.
- Device Description: A system of titanium abutments, screws, counter torque devices, temporary components, and impression copings, designed to anchor single crowns or multi-unit bridges to dental implants.
- Intended Use: To function as an anchor for prosthetic devices (artificial teeth) to restore chewing function.
- Safety and Effectiveness Concerns (Identified with similar abutment systems): Occasional screw fractures due to overload, loose screws leading to granulation tissue/infection, improper seating causing gingival inflammation/fistulae, and abutment screw fracture from poorly designed restorations.
- Regulatory Information: Classified as an Endosseous Dental Implant Abutment (21 CFR 872.3630), Class II, product code NHA.
It does NOT include:
- A table of acceptance criteria or reported device performance.
- Details about a specific study (sample size, data provenance, expert involvement, adjudication, etc.) to demonstrate meeting acceptance criteria.
- Information on a multi-reader multi-case (MRMC) study or standalone algorithm performance.
- Details regarding training set size or its ground truth establishment.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing new clinical trials with pre-defined acceptance criteria in the same way a PMA (Premarket Approval) might require. The "Summary of Safety and Effectiveness Concerns" in this document refers to known issues with similar devices, not specific performance metrics of the submitted device.
§ 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.)