The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Bosworth Super Bond Dental Adhesive.
Device ID | K842448 |
510k Number | K842448 |
Device Name: | BOSWORTH SUPER BOND DENTAL ADHESIVE |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | HARRY J. BOSWORTH CO. 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 | 1984-06-22 |
Decision Date | 1984-09-27 |