The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Contac, A Dentin Sealant.
| Device ID | K881026 |
| 510k Number | K881026 |
| Device Name: | CONTAC, A DENTIN SEALANT |
| Classification | Varnish, Cavity |
| Applicant | HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
| Contact | Jacqueline N Ruffo |
| Correspondent | Jacqueline N Ruffo HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-10 |
| Decision Date | 1988-06-01 |