K200555 is an FDA 510(k) clearance for the Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner). This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Prevest Denpro Limited (Bari Brahmana, IN). The FDA issued a Cleared decision on May 13, 2021, 436 days after receiving the submission on March 3, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K200555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2020 |
| Decision Date | May 13, 2021 |
| Days to Decision | 436 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EMA - Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |