K213244 is an FDA 510(k) clearance for the Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration). This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Prevest Denpro Limited (Bari Brahmana, IN). The FDA issued a Cleared decision on September 9, 2022, 344 days after receiving the submission on September 30, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K213244 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2021 |
| Decision Date | September 09, 2022 |
| Days to Decision | 344 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELW - Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |