The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Bonding Agent, Prestige.
Device ID | K760324 |
510k Number | K760324 |
Device Name: | BONDING AGENT, PRESTIGE |
Classification | Agent, Tooth Bonding, Resin |
Applicant | LEE PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-26 |
Decision Date | 1976-08-03 |