The following data is part of a premarket notification filed by Sci-pharm, Inc. with the FDA for Beauseal.
| Device ID | K812549 |
| 510k Number | K812549 |
| Device Name: | BEAUSEAL |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | SCI-PHARM, INC. 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 | 1981-09-04 |
| Decision Date | 1981-09-25 |