The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Argion Dental Cement.
Device ID | K926492 |
510k Number | K926492 |
Device Name: | ARGION DENTAL CEMENT |
Classification | Cement, Dental |
Applicant | VOCO GMBH 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
Contact | Evan G Dick |
Correspondent | Evan G Dick VOCO GMBH 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-29 |
Decision Date | 1993-04-08 |