The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Temp. Bridge, Posterior 3-unit.
Device ID | K772126 |
510k Number | K772126 |
Device Name: | TEMP. BRIDGE, POSTERIOR 3-UNIT |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | LEE PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-11-11 |
Decision Date | 1978-01-03 |