The following data is part of a premarket notification filed by Danville Materials, Inc. with the FDA for Starflow Hv.
Device ID | K020760 |
510k Number | K020760 |
Device Name: | STARFLOW HV |
Classification | Material, Tooth Shade, Resin |
Applicant | DANVILLE MATERIALS, INC. 2021 OMEGA DR. San Ramon, CA 94583 |
Contact | Craig R Bruns |
Correspondent | Craig R Bruns DANVILLE MATERIALS, INC. 2021 OMEGA DR. 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 | 2002-03-07 |
Decision Date | 2002-05-03 |
Summary: | summary |