The following data is part of a premarket notification filed by Pentron Corp. with the FDA for C-22 Pit & Fissure Sealant.
| Device ID | K844057 |
| 510k Number | K844057 |
| Device Name: | C-22 PIT & FISSURE SEALANT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | PENTRON CORP. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
| Contact | Martin L Schulman |
| Correspondent | Martin L Schulman PENTRON CORP. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-18 |
| Decision Date | 1984-12-03 |