The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Bruxzir Gt (gum Tissue) Color.
| Device ID | K191903 |
| 510k Number | K191903 |
| Device Name: | BruxZir GT (Gum Tissue) Color |
| Classification | Powder, Porcelain |
| Applicant | Prismatik Dentalcraft, Inc. 2212 Dupont Dr. Irvine, CA 92612 |
| Contact | Mythili Reguraman |
| Correspondent | Mythili Reguraman Prismatik Dentalcraft, Inc. 2212 Dupont Dr. 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 | 2019-07-16 |
| Decision Date | 2019-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D745701123BCL00350 | K191903 | 000 |