NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION

• K Number: K132746
• Device Name: NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION
• Manufacturer: NOBEL BIOCARE USA, LLC
• Date Cleared: 2014-01-30 ( 149 days)
• Product Code: NHA
• Regulation Number: 872.3630

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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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.)

Summary

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