AART CHIN IMPLANT
FDA 510(k) clearance K021417 · decided 2002-07-02
Clearance details
- K-number
- K021417
- Device name
- AART CHIN IMPLANT
- Applicant
- Aesthetic and Reconstructive Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-03
- Decision date
- 2002-07-02
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- FWP
- Device class
- 2
- Regulation number
- 878.3550
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Reno, NV, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 C recall (Z-0946-2026) | DSAART LLC | 2025-12-18 |