The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for New Restodent.
| Device ID | K780965 |
| 510k Number | K780965 |
| Device Name: | NEW RESTODENT |
| Classification | Material, Tooth Shade, Resin |
| Applicant | LEE PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-12 |
| Decision Date | 1978-06-22 |