The following data is part of a premarket notification filed by Voco Gmbh with the FDA for F21(r) Dental Cement.
Device ID | K914073 |
510k Number | K914073 |
Device Name: | F21(R) DENTAL CEMENT |
Classification | Cement, Dental |
Applicant | VOCO GMBH C/ONDA RESOURCES 790 WASHINGTON STREET, STE 301 Denver, CO 80203 |
Contact | Gail E Gillenwater |
Correspondent | Gail E Gillenwater VOCO GMBH C/ONDA RESOURCES 790 WASHINGTON STREET, STE 301 Denver, CO 80203 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-11 |
Decision Date | 1991-10-21 |