The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Command Ultraseal Pit & Fissure Sealant.
| Device ID | K843024 |
| 510k Number | K843024 |
| Device Name: | COMMAND ULTRASEAL PIT & FISSURE SEALANT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | KERR CORPORATION (DANBURY) 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-01 |
| Decision Date | 1984-09-27 |