The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Seal & Bond Direct Bonding Orthodontic.
| Device ID | K790962 |
| 510k Number | K790962 |
| Device Name: | SEAL & BOND DIRECT BONDING ORTHODONTIC |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-22 |
| Decision Date | 1979-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D801SP600241 | K790962 | 000 |
| D801SP60016B1 | K790962 | 000 |
| D801SP60016 | K790962 | 000 |