The following data is part of a premarket notification filed by Prevest Denpro Limited with the FDA for Prevest Denpro Cavity Liners (apacal Art, Cal Lc, Calcigel, Calultra).
| Device ID | K212475 |
| 510k Number | K212475 |
| Device Name: | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) |
| Classification | Liner, Cavity, Calcium Hydroxide |
| 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 -0172 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-06 |
| Decision Date | 2022-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D96730001A04 | K212475 | 000 |
| D967300010 | K212475 | 000 |