Aart Chin Implant

FDA 510(k) K021417 · Aesthetic and Reconstructive Technologies, Inc.

Substantially Equivalent

510(k) numberK021417

Submission

Device name
Aart Chin Implant
Applicant
Aesthetic and Reconstructive Technologies, Inc.
Reno, NV, US
Received
May 3, 2002
Decision date
July 2, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FWP – Prosthesis, Chin, Internal
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3550
Specialty
General, Plastic Surgery
Implant
Yes

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More from Howmedica Osteonics Corp.

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K022223Aart Silicone SheetingMIB · Traditional 08/08/2002SE
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K021820Aart Silicone Carving BlockMIB · Traditional 07/16/2002SE
K021337Aart Pectoralis ImplantMIC · Traditional 07/03/2002SE
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Questions and answers

When was Aart Chin Implant cleared by the FDA?

Aart Chin Implant (K021417) received a 510(k) decision of Substantially Equivalent on July 2, 2002, 60 days after the submission was received.

What is the product code of K021417?

The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.