The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Fissure Sealer And Bonding Agent.
| Device ID | K790788 |
| 510k Number | K790788 |
| Device Name: | FISSURE SEALER AND BONDING AGENT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | SCIENTIFIC PHARMACEUTICALS, 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 | 1979-04-24 |
| Decision Date | 1979-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816526021432 | K790788 | 000 |
| D801SP5101S1 | K790788 | 000 |
| D801SP51011 | K790788 | 000 |
| D801SP50117N1 | K790788 | 000 |
| D801SP50116N1 | K790788 | 000 |
| D801SP50065N1 | K790788 | 000 |
| D801SP50065B1 | K790788 | 000 |
| D801SP50014N1 | K790788 | 000 |
| D801SP50014B1 | K790788 | 000 |
| D801SP50012B1 | K790788 | 000 |
| D801SP500121 | K790788 | 000 |
| D801SP50011B1 | K790788 | 000 |
| D801SP500111 | K790788 | 000 |
| D801SP52011 | K790788 | 000 |
| D801SP520111 | K790788 | 000 |
| 00816526020305 | K790788 | 000 |
| D801SP5401S1 | K790788 | 000 |
| D801SP54011N1 | K790788 | 000 |
| D801SP54011B1 | K790788 | 000 |
| D801SP54011 | K790788 | 000 |
| D801SP5301S1 | K790788 | 000 |
| D801SP530111 | K790788 | 000 |
| D801SP53011 | K790788 | 000 |
| D801SP5201S1 | K790788 | 000 |
| D801SP52012B1 | K790788 | 000 |
| D801SP520121 | K790788 | 000 |
| D801SP52011B1 | K790788 | 000 |
| D801SP50011 | K790788 | 000 |