The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Bruxzir Steel.
| Device ID | K200131 |
| 510k Number | K200131 |
| Device Name: | BruxZir Steel |
| Classification | Powder, Porcelain |
| Applicant | Prismatik Dentalcraft, Inc. 2212 Dupont Drive, Suite P Irvine, CA 92612 |
| Contact | So Hyun Park |
| Correspondent | So Hyun Park 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 | 2020-01-21 |
| Decision Date | 2020-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D745701014BXS00010 | K200131 | 000 |