The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Restodent Vl.
| Device ID | K843363 |
| 510k Number | K843363 |
| Device Name: | RESTODENT VL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | LEE PHARMACEUTICALS P.O. BOX 3836 South El Monte , CA 91733 - |
| Contact | Dian Teigler |
| Correspondent | Dian Teigler LEE PHARMACEUTICALS P.O. BOX 3836 South El Monte , CA 91733 - |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-28 |
| Decision Date | 1984-10-25 |