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 |