The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Liner, Cavity Calcium Hydroxide.
| Device ID | K781688 |
| 510k Number | K781688 |
| Device Name: | LINER, CAVITY CALCIUM HYDROXIDE |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | KERR CORPORATION (DANBURY) 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-04 |
| Decision Date | 1978-12-20 |