The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Megabond System.
| Device ID | K930583 |
| 510k Number | K930583 |
| Device Name: | MEGABOND SYSTEM |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. MILLY GOLDSTEIN 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
| Contact | Bosworth Co |
| Correspondent | Bosworth Co SCIENTIFIC PHARMACEUTICALS, INC. MILLY GOLDSTEIN 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-04 |
| Decision Date | 1994-02-22 |