The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Superfil Light & Superfil Bonding System.
Device ID | K811427 |
510k Number | K811427 |
Device Name: | SUPERFIL LIGHT & SUPERFIL BONDING SYSTEM |
Classification | Material, Tooth Shade, Resin |
Applicant | HARRY J. BOSWORTH CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-05-22 |
Decision Date | 1981-08-20 |