The following data is part of a premarket notification filed by Hoyt Laboratories with the FDA for Replica Acid-etch.
Device ID | K771883 |
510k Number | K771883 |
Device Name: | REPLICA ACID-ETCH |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | HOYT LABORATORIES 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 | 1977-10-04 |
Decision Date | 1977-10-20 |