The following data is part of a premarket notification filed by Danville Materials Llc with the FDA for Prestige.
Device ID | K151514 |
510k Number | K151514 |
Device Name: | Prestige |
Classification | Material, Tooth Shade, Resin |
Applicant | DANVILLE MATERIALS LLC 3420 FOSTORIA WAY SUITE A-200 San Ramon, CA 94583 |
Contact | Dong Hua |
Correspondent | Dong Hua DANVILLE MATERIALS LLC 3420 FOSTORIA WAY SUITE A-200 San Ramon, CA 94583 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-05 |
Decision Date | 2015-09-21 |
Summary: | summary |