Infinity® 039670100

GUDID D8130396701000

INFINITY SY KIT

DEN-MAT HOLDINGS, LLC

Dental composite resin

• Primary Device ID: D8130396701000
• NIH Device Record Key: 1b9d1198-aa97-4bc6-9bcd-d0410bd66513
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinity®
• Version Model Number: 039670100
• Catalog Number: 039670100
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store under refrigeration only
• Special Storage Condition, Specify: Between 0 and 0 *Store under refrigeration only
• Special Storage Condition, Specify: Between 0 and 0 *Store under refrigeration only
• Special Storage Condition, Specify: Between 0 and 0 *Store under refrigeration only
• Special Storage Condition, Specify: Between 0 and 0 *Store under refrigeration only
• Special Storage Condition, Specify: Between 0 and 0 *Store under refrigeration only
• Special Storage Condition, Specify: Between 0 and 0 *Store under refrigeration only
• Special Storage Condition, Specify: Between 0 and 0 *Store under refrigeration only
• Special Storage Condition, Specify: Between 0 and 0 *Store under refrigeration only
• Special Storage Condition, Specify: Between 0 and 0 *Store under refrigeration only
• Special Storage Condition, Specify: Between 0 and 0 *Store under refrigeration only
• Special Storage Condition, Specify: Between 0 and 0 *Store under refrigeration only
• Special Storage Condition, Specify: Between 0 and 0 *Store under refrigeration only
• Special Storage Condition, Specify: Between 0 and 0 *Store under refrigeration only
• Special Storage Condition, Specify: Between 0 and 0 *Store under refrigeration only
• Special Storage Condition, Specify: Between 0 and 0 *Store under refrigeration only
• Special Storage Condition, Specify: Between 0 and 0 *Store under refrigeration only

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8130396701000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K881918

FDA Product Code

• EMA: Cement, Dental

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