BrackFix

GUDID E22112081

VOCO GmbH

Orthodontic bracket adhesive

• Primary Device ID: E22112081
• NIH Device Record Key: 997510df-7428-4ec1-9a93-4c7b3c7c4c52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BrackFix
• Version Model Number: 1208
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 999-999-9999
• Email: xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E22112081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183147

FDA Product Code

• DYH: Adhesive, Bracket And Tooth Conditioner, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-13
• Device Publish Date: 2019-03-05

On-Brand Devices [BrackFix]

• E22112091: 1209
• E22112081: 1208
• E22112071: 1207
• E22112061: 1206
• E22112051: 1205