The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Restodent Posterior.
Device ID | K863157 |
510k Number | K863157 |
Device Name: | RESTODENT POSTERIOR |
Classification | Material, Tooth Shade, Resin |
Applicant | LEE PHARMACEUTICALS 1444 SANTA ANITA P.O. BOX 3836 South El Monte, CA 91733 |
Contact | Teigler, Ph.d. |
Correspondent | Teigler, Ph.d. 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 | 1986-08-15 |
Decision Date | 1986-09-25 |