The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Bruxzir Shaded.
Device ID | K130924 |
510k Number | K130924 |
Device Name: | BRUXZIR SHADED |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-04-03 |
Decision Date | 2013-05-16 |
Summary: | summary |