The following data is part of a premarket notification filed by Medental Intl. with the FDA for Polycarboxylate Cement.
| Device ID | K980990 |
| 510k Number | K980990 |
| Device Name: | POLYCARBOXYLATE CEMENT |
| Classification | Cement, Dental |
| Applicant | MEDENTAL INTL. 1246 CLEAR CREEK RD. Evergreen, CO 80434 |
| Contact | Debra Olson |
| Correspondent | Debra Olson MEDENTAL INTL. 1246 CLEAR CREEK RD. Evergreen, CO 80434 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-17 |
| Decision Date | 1998-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| P07502291840028 | K980990 | 000 |