510(k) K021419 ยท LZK Implant, Malar
AART MALAR IMPLANT
| Applicant | Aesthetic and Reconstructive Technologies, Inc., Reno NV, US |
| Decision | Substantially Equivalent, Jul 2, 2002 |
| Received | May 3, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021419
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | DSAART LLC Brand Name: AART Malar Implant
Product Name: Malar Implant
Model/Catalog Number:
401-202-5 Malar Implant style 2 size 2 left
UDI-DI code: B4904012025
401-202-6 Malar Implant style 2 size 2 right
UDI- Open, Classified |
LZK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.