The following data is part of a premarket notification filed by Prevest Denpro Limited with the FDA for Prevest Denpro Dental Cements (micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner).
| Device ID | K200555 |
| 510k Number | K200555 |
| Device Name: | Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) |
| Classification | Cement, Dental |
| Applicant | Prevest Denpro Limited Export Promotion Industrial Park Bari Brahmana, IN 181133 |
| Contact | Atul Modi |
| Correspondent | Angela Blackwell Blackwell Device Consulting P.O. BOX 718 Gresham, OR 97030 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-03 |
| Decision Date | 2021-05-13 |