Infinity® 039681030

GUDID D8130396810300

INFNTY DCHMB SY SMP BG 1FLW IT

DEN-MAT HOLDINGS, LLC

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: D8130396810300
• NIH Device Record Key: 9e8d4188-6a7a-451d-85c6-3e83a32f6ae4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinity®
• Version Model Number: 039681030
• Catalog Number: 039681030
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8130396810300 [Primary]

FDA Product Code

• EMA: Cement, Dental

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: 2022-09-30
• Device Publish Date: 2022-09-22

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