Infinity® 8000

GUDID D81380000

SOLVENEX 8oz

DEN-MAT HOLDINGS, LLC

Orthodontic bracket adhesive

• Primary Device ID: D81380000
• NIH Device Record Key: ea901be2-a155-4754-be2a-c50070a190a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinity®
• Version Model Number: 8000
• Catalog Number: 8000
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• 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: 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	D81380000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K771974

FDA Product Code

• KZP: Solution, Cement Disolving

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Infinity®]

• D81380000: SOLVENEX 8oz
• D8130396901100: INFINITY SY INTRO KIT
• D8130396812000: INFINITY SE SY VALUE KIT
• D8130396802000: INFINITY SE SY KIT
• D8130396801000: INFINITY SY VALUE KIT
• D8130396701000: INFINITY SY KIT
• D8130396201500: INFINITY ORIGINAL A & B KIT
• D8130396810300: INFNTY DCHMB SY SMP BG 1FLW IT