The following data is part of a premarket notification filed by Besorah Dental Solutions Nz Limited with the FDA for Ethanzir Zirconia.
| Device ID | K191304 |
| 510k Number | K191304 |
| Device Name: | EthanZir Zirconia |
| Classification | Powder, Porcelain |
| Applicant | Besorah Dental Solutions NZ Limited 17/9 Chonny Crescent, Manurewa Auckland, NZ 2102 |
| Contact | Jobin Jose |
| Correspondent | Robin A. Carden RAC Corporation 27134 Paseo Espada San Juan Capistrano, CA 92675 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-14 |
| Decision Date | 2019-11-04 |