The following data is part of a premarket notification filed by Medental Intl. with the FDA for Medental Glass Ionomer Cement Type I And Mirage Glass Ionomer Cement Type 1.
| Device ID | K982779 |
| 510k Number | K982779 |
| Device Name: | MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1 |
| Classification | Cement, Dental |
| Applicant | MEDENTAL INTL. 12422 W. 16TH DR. Lakewood, CO 80215 |
| Contact | Debra Olson |
| Correspondent | Debra Olson MEDENTAL INTL. 12422 W. 16TH DR. Lakewood, CO 80215 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-07 |
| Decision Date | 1998-09-30 |