The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Sci-pharm Paint-on Restorative.
| Device ID | K791067 |
| 510k Number | K791067 |
| Device Name: | SCI-PHARM PAINT-ON RESTORATIVE |
| Classification | Coating, Filling Material, Resin |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBD |
| CFR Regulation Number | 872.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-12 |
| Decision Date | 1979-08-10 |