The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Xr Primer.
| Device ID | K880684 |
| 510k Number | K880684 |
| Device Name: | XR PRIMER |
| Classification | Agent, Tooth Bonding, Resin |
| 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-19 |
| Decision Date | 1988-05-11 |