The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Hapi Seal.
| Device ID | K162598 |
| 510k Number | K162598 |
| Device Name: | HAPI Seal |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Contact | Ryan Hobson |
| Correspondent | Ryan Hobson BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-19 |
| Decision Date | 2017-05-23 |
| Summary: | summary |