The following data is part of a premarket notification filed by Dmg Chemisch Pharmazeutische Fabrik Gmbh with the FDA for Ionosit Bond.
| Device ID | K991172 |
| 510k Number | K991172 |
| Device Name: | IONOSIT BOND |
| Classification | Cement, Dental |
| Applicant | DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH 5 WHITCOMB AVE. Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH 5 WHITCOMB AVE. Ayer, MA 01432 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-07 |
| Decision Date | 1999-05-17 |
| Summary: | summary |