The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Bruxzir Opaque Coloring Liquid.
| Device ID | K220960 |
| 510k Number | K220960 |
| Device Name: | BruxZir Opaque Coloring Liquid |
| Classification | Powder, Porcelain |
| Applicant | Prismatik Dentalcraft, Inc. 2144 Michelson Drive Irvine, CA 92612 |
| Contact | So Hyun Park |
| Correspondent | So Hyun Park Prismatik Dentalcraft, Inc. 2144 Michelson Drive 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 | 2022-04-01 |
| Decision Date | 2022-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D745701123BRX00050 | K220960 | 000 |
| D745701123BRX00160 | K220960 | 000 |
| D745701123BRX00150 | K220960 | 000 |
| D745701123BRX00140 | K220960 | 000 |
| D745701123BRX00130 | K220960 | 000 |
| D745701123BRX00120 | K220960 | 000 |
| D745701123BRX00110 | K220960 | 000 |
| D745701123BRX00100 | K220960 | 000 |
| D745701123BRX00090 | K220960 | 000 |
| D745701123BRX00080 | K220960 | 000 |
| D745701123BRX00070 | K220960 | 000 |
| D745701123BRX00170 | K220960 | 000 |
| D745701123BRX00180 | K220960 | 000 |
| D745701123BRX00040 | K220960 | 000 |
| D745701123BRX00030 | K220960 | 000 |
| D745701123BRX00020 | K220960 | 000 |
| D745701123BRX00010 | K220960 | 000 |
| D745701123BRX00240 | K220960 | 000 |
| D745701123BRX00230 | K220960 | 000 |
| D745701123BRX00220 | K220960 | 000 |
| D745701123BRX00210 | K220960 | 000 |
| D745701123BRX00200 | K220960 | 000 |
| D745701123BRX00190 | K220960 | 000 |
| D745701123BRX00060 | K220960 | 000 |