The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Jumbo Glass Ionomer Cement.
| Device ID | K980568 |
| 510k Number | K980568 |
| Device Name: | JUMBO GLASS IONOMER CEMENT |
| Classification | Cement, Dental |
| Applicant | CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
| Contact | John Discko |
| Correspondent | John Discko CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-09 |
| Decision Date | 1998-04-30 |