The following data is part of a premarket notification filed by Novocol, Inc. with the FDA for Orthodontic Flowable Bracket Adhesive.
Device ID | K120619 |
510k Number | K120619 |
Device Name: | ORTHODONTIC FLOWABLE BRACKET ADHESIVE |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | NOVOCOL, INC. 416 S Taylor Ave Louisville, CO 80027 |
Contact | Steve Rudolph |
Correspondent | Steve Rudolph NOVOCOL, INC. 416 S Taylor Ave Louisville, CO 80027 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-29 |
Decision Date | 2012-05-21 |