SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM

• K Number: K062749
• Device Name: SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM
• Manufacturer: NOBEL BIOCARE AB
• Date Cleared: 2006-11-29 ( 76 days)
• Product Code: NHA
• Regulation Number: 872.3630
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: K061003

Intended Use

Nobel Biocare's SFB and CFB Angled Abutments are premanufactured prosthetic components directly connected to the SFB & CFB endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Device Description

Nobel Biocare's SFB and CFB angled abutments are artificial tooth abutments designed to fit and function on the SFB and CFB implants. SFB and CFB angled abutments differ from the predicate SFB and CFB abutments in that the abutments are angled. The angled abutments provide for more flexibility in the implant placement and restoration process.

AI/ML Overview

The provided text is a 510(k) summary for the Nobel Biocare SFB & CFB Angled Abutments. This document primarily describes the device, its intended use, and its substantial equivalence to a predicate device, which is a regulatory pathway for medical devices in the US.

It does not contain information about:

• Specific acceptance criteria for device performance.
• A study proving the device meets acceptance criteria, including sample sizes, data provenance, expert qualifications, or adjudication methods for ground truth establishment.
• A multi-reader multi-case (MRMC) comparative effectiveness study, nor effects of AI assistance.
• A standalone algorithm performance study.
• Sample size for a training set or how ground truth for a training set was established.

This type of document is a regulatory submission focused on demonstrating the safety and effectiveness of a new device by comparing it to an already legally marketed predicate device, rather than presenting a detailed performance study with quantifiable acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

Regulation Number and Section

§ 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.)