IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)

• K Number: K002886
• Device Name: IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
• Manufacturer: IMPLANTECH ASSOCIATES, INC.
• Date Cleared: 2000-11-24 ( 70 days)
• Product Code: LZK
• Regulation Number: 878.3550
• Type: Traditional
• Panel: General & Plastic Surgery
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: K091011 , K172389

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 878.3550 Chin prosthesis.

(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.