The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Kulzer Glas-ionomer Cement.
Device ID | K892453 |
510k Number | K892453 |
Device Name: | KULZER GLAS-IONOMER CEMENT |
Classification | Cement, Dental |
Applicant | KULZER, INC. 111 N. WABASH AVE. Chicago, IL 60602 |
Contact | Bauer, Phd |
Correspondent | Bauer, Phd KULZER, INC. 111 N. WABASH AVE. Chicago, IL 60602 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-10 |
Decision Date | 1989-12-04 |