The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Adhesive Hybrid Ionomer Cement.
| Device ID | K974140 |
| 510k Number | K974140 |
| Device Name: | ADHESIVE HYBRID IONOMER CEMENT |
| Classification | Cement, Dental |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Contact | Jeffery P Lehn |
| Correspondent | Jeffery P Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-03 |
| Decision Date | 1998-01-05 |
| Summary: | summary |