VAKT PRIVATE LABEL

GUDID D8130562005500

VAKT RETAINER UPPER

DEN-MAT HOLDINGS, LLC

Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer

• Primary Device ID: D8130562005500
• NIH Device Record Key: c23275b1-ff8c-4872-8afa-04d4d25cb3f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VAKT PRIVATE LABEL
• Version Model Number: 056200550
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8130562005500 [Primary]

FDA Product Code

• DYJ: Retainer, Screw Expansion, Orthodontic

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: 2023-03-14
• Device Publish Date: 2023-03-06

On-Brand Devices [VAKT PRIVATE LABEL]

• D8130562005550: VAKT RETAINER LOWER
• D8130562005500: VAKT RETAINER UPPER
• D8130562005300: VAKT ALIGNER UPPER