The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Bruxzir Anterior Milling Blanks.
| Device ID | K150872 |
| 510k Number | K150872 |
| Device Name: | BruxZir Anterior Milling Blanks |
| Classification | Powder, Porcelain |
| Applicant | PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE SUITE P Irvine, CA 92612 |
| Contact | Armin Zehtabchi |
| Correspondent | Armin Zehtabchi PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE SUITE P Irvine, CA 92612 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-01 |
| Decision Date | 2015-07-02 |