The following data is part of a premarket notification filed by 3m Company with the FDA for Scotchbond Dental Adhesive.
Device ID | K813180 |
510k Number | K813180 |
Device Name: | SCOTCHBOND DENTAL ADHESIVE |
Classification | Agent, Tooth Bonding, Resin |
Applicant | 3M COMPANY 8124 PACIFIC AVE. White City, OR 97503 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-12 |
Decision Date | 1982-01-12 |