AART CHIN IMPLANT— 510(k) K021417

Clearance details

Applicant

Aesthetic and Reconstructive Technologies, Inc.

Product code

Code FWP

Device class

Class 2

Regulation

21 CFR 878.3550

Advisory panel

General, Plastic Surgery

Date received

2002-05-03

Decision date

2002-07-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Reno, NV, US

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• K023678 — DIMISIL SCAR GEL2003-01-23
• K022306 — AART SILICONE TUBING2002-10-10
• K022511 — AART CALF IMPLANT2002-08-26
• K022223 — AART SILICONE SHEETING2002-08-08
• K021820 — AART SILICONE CARVING BLOCK2002-07-16

• Z-0946-2026 — Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103 Chin Implant style 1 size 3 UDI-DI code: B490400103 400-0104 Chin Implant style 1 size 4 UDI-DI code: B490400104 400-0201 Chin Implant style 2 size 1 UDI-DI code: B490400201 400-0202 Chin Implant style 2 size 2 UDI-DI code: B490400202 400-0301 Chin Implant style 3 size 1 UDI-DI code: B49044301 400-0302 Chin Implant style 3 size 2 UDI-DI code: B490400302Class II·Ongoing·DSAART LLC·20250926

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021417.