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Chin (Mentoplasty) Implants

FDA 510(k)

Class II (US FDA 510(k))

510(k) K831724

by S. Jackson, Inc.

Identifiers

510(k) Number
K831724 FDA 510(k)
FDA Product Code
FWP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.3550 FDA 510(k)
Regulation Number
878.3550 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is a Prosthesis, Chin, Internal (FDA classification FWP) designed for chin augmentation or reshaping via mentoplasty. These implants are intended to correct facial asymmetry, enhance chin projection, or restore proportions following bone resorption or trauma, as classified under FDA regulation 878.3550.

The implants are supplied sterile and intended for single-use in an operating room setting. They are classified as Class II devices under the FDA and were granted FDA 510(k) clearance (K831724) in 1983 via a Subcommittee on Urology (SU) review. Multiple reference codes (e.g., 3002821504, 3003070421) correspond to distinct implant sizes or variants, all intended for surgical use by qualified plastic surgeons.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CHIN (MENTOPLASTY) IMPLANTS (K831724) — FDA 510(k) | Innolitics, Chin Surgery - American Society of Plastic Surgeons, Chin Implants Jacksonville Mentoplasty

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
S. Jackson, Inc.

Sources (1)

  • FDA 510(k) K831724 24 fields · synced Sep 19, 2026