The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Zionomer Cement.
| Device ID | K852196 |
| 510k Number | K852196 |
| Device Name: | ZIONOMER CEMENT |
| Classification | Cement, Dental |
| Applicant | DEN-MAT CORP. P.O. BOX 1729 Santa Maria, CA 93456 |
| Contact | Robert L Ibsen |
| Correspondent | Robert L Ibsen DEN-MAT CORP. P.O. BOX 1729 Santa Maria, CA 93456 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-20 |
| Decision Date | 1985-06-20 |