The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Temp Bond Ne.
| Device ID | K894219 |
| 510k Number | K894219 |
| Device Name: | TEMP BOND NE |
| Classification | Cement, Dental |
| Applicant | KERR CORPORATION (DANBURY) SUITE 1200 Washington, DC 20005 |
| Contact | Stephen Kurzman |
| Correspondent | Stephen Kurzman KERR CORPORATION (DANBURY) SUITE 1200 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 | 1989-06-19 |
| Decision Date | 1989-09-18 |