K223892 is an FDA 510(k) clearance for the DentMix VPS Impression Material. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Innovative Product Brands, Inc. (Highland, US). The FDA issued a Cleared decision on April 27, 2023, 120 days after receiving the submission on December 28, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K223892 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2022 |
| Decision Date | April 27, 2023 |
| Days to Decision | 120 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 |