BrackFix

GUDID E22112081

VOCO GmbH

Orthodontic bracket adhesive
Primary Device IDE22112081
NIH Device Record Key997510df-7428-4ec1-9a93-4c7b3c7c4c52
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrackFix
Version Model Number1208
Company DUNS316699578
Company NameVOCO GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone999-999-9999
Emailxxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE22112081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYHAdhesive, Bracket And Tooth Conditioner, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-13
Device Publish Date2019-03-05

On-Brand Devices [BrackFix]

E221120911209
E221120811208
E221120711207
E221120611206
E221120511205

Trademark Results [BrackFix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BRACKFIX
BRACKFIX
79184443 5033946 Live/Registered
Voco GmbH
2016-01-27

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