BrackFix
Adhesive, Bracket And Tooth Conditioner, Resin
VOCO GmbH
The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Brackfix.
Pre-market Notification Details
| Device ID | K183147 |
| 510k Number | K183147 |
| Device Name: | BrackFix |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven, DE |
| Contact | M. Th. Plaumann |
| Correspondent | T Gerkensmeier VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven, DE |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-13 |
| Decision Date | 2019-03-01 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22112091 | K183147 | 000 |
| E22112081 | K183147 | 000 |
| E22112071 | K183147 | 000 |
| E22112061 | K183147 | 000 |
| E22112051 | K183147 | 000 |
Trademark Results [BrackFix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BRACKFIX 79184443 5033946 Live/Registered |
Voco GmbH 2016-01-27 |
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