The following data is part of a premarket notification filed by 3m Unitek with the FDA for Apc Plus Adhesive.
Device ID | K020394 |
510k Number | K020394 |
Device Name: | APC PLUS ADHESIVE |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | 3M UNITEK 2724 SOUTH PECK RD. Monrovia, CA 91016 |
Contact | Marlyn Scheff |
Correspondent | Marlyn Scheff 3M UNITEK 2724 SOUTH PECK RD. Monrovia, CA 91016 |
Product Code | DYH |
Subsequent Product Code | DYW |
Subsequent Product Code | EJF |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-06 |
Decision Date | 2002-04-12 |