The following data is part of a premarket notification filed by Prevest Denpro Limited with the FDA for 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).
| Device ID | K213244 |
| 510k Number | K213244 |
| Device Name: | 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) |
| Classification | Material, Impression |
| 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 | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-30 |
| Decision Date | 2022-09-09 |