The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Prosthodent Vl.
| Device ID | K881903 |
| 510k Number | K881903 |
| Device Name: | PROSTHODENT VL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | LEE PHARMACEUTICALS 1444 SANTA ANITA P.O. BOX 3836 South El Monte, CA 91733 |
| Contact | Teigler, Phd |
| Correspondent | Teigler, Phd LEE PHARMACEUTICALS 1444 SANTA ANITA 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 | 1988-05-06 |
| Decision Date | 1988-07-01 |