The following data is part of a premarket notification filed by Sybron Corp. with the FDA for Everbond Glass Ionomer Cement.
Device ID | K823795 |
510k Number | K823795 |
Device Name: | EVERBOND GLASS IONOMER CEMENT |
Classification | Cement, Dental |
Applicant | SYBRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-27 |
Decision Date | 1983-01-26 |