The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Universal Paste Stains And Glaze.
| Device ID | K130604 |
| 510k Number | K130604 |
| Device Name: | UNIVERSAL PASTE STAINS AND GLAZE |
| Classification | Powder, Porcelain |
| Applicant | PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DR., SUITE JJK Irvine, CA 92612 |
| Contact | Armin Zehtabchi |
| Correspondent | Armin Zehtabchi PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DR., SUITE JJK 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 | 2013-03-07 |
| Decision Date | 2013-09-12 |
| Summary: | summary |