The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Kerr Xr Ionomer.
| Device ID | K880251 |
| 510k Number | K880251 |
| Device Name: | KERR XR IONOMER |
| Classification | Cement, Dental |
| Applicant | KERR CORPORATION (DANBURY) ONE THOMAS CIRCLE Washington, DC 20005 |
| Contact | Kurzman, Pc |
| Correspondent | Kurzman, Pc KERR CORPORATION (DANBURY) ONE THOMAS CIRCLE Washington, DC 20005 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-20 |
| Decision Date | 1988-06-01 |