The following data is part of a premarket notification filed by Vident with the FDA for Vita Cerec Duo Cement.
Device ID | K925713 |
510k Number | K925713 |
Device Name: | VITA CEREC DUO CEMENT |
Classification | Cement, Dental |
Applicant | VIDENT 5130 COMMERCE DR. Baldwin Park, CA 91706 |
Contact | Ray E Morrow |
Correspondent | Ray E Morrow VIDENT 5130 COMMERCE DR. Baldwin Park, CA 91706 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-12 |
Decision Date | 1993-02-17 |