The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Obsidian Ceramic Blocks.
| Device ID | K100781 |
| 510k Number | K100781 |
| Device Name: | OBSIDIAN CERAMIC BLOCKS |
| Classification | Powder, Porcelain |
| Applicant | PRISMATIK DENTALCRAFT, INC. 4141 MACARTHUR BLVD Newport Beach, CA 92660 |
| Contact | Keith Allred |
| Correspondent | Keith Allred PRISMATIK DENTALCRAFT, INC. 4141 MACARTHUR BLVD Newport Beach, CA 92660 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-19 |
| Decision Date | 2010-06-21 |
| Summary: | summary |