The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Bisco Pit And Fissure Sealant.
| Device ID | K874556 |
| 510k Number | K874556 |
| Device Name: | BISCO PIT AND FISSURE SEALANT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | BISCO, INC. 3010-J WOODCREEK DR. Downers Grove, IL 60515 -5409 |
| Contact | Byoung I Suh |
| Correspondent | Byoung I Suh BISCO, INC. 3010-J WOODCREEK DR. Downers Grove, IL 60515 -5409 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-04 |
| Decision Date | 1988-01-28 |