The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Obsidian Milling Blocks.
| Device ID | K141788 |
| 510k Number | K141788 |
| Device Name: | OBSIDIAN MILLING BLOCKS |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-02 |
| Decision Date | 2014-08-20 |
| Summary: | summary |