510(k) K021820 ยท MIB Elastomer, Silicone Block
AART SILICONE CARVING BLOCK
| Applicant | Aesthetic and Reconstructive Technologies, Inc., Paso Robles CA, US |
| Decision | Substantially Equivalent, Jul 16, 2002 |
| Received | Jun 4, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021820
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | DSAART LLC Brand Name: AART Silicone Carving Implant
Product Name: Silicone Carving Implant
Model/Catalog Numbers:
600-601 - Silicone Carving Implant Style 6 Size 1
UDI-DI code: B490600601
600-602 - Silicone Ca Open, Classified |
MIB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.