Virtuoso® 030381962

GUDID D8130303819621

VIRT UNIV ENM TRNS 10pc BAGGED

DEN-MAT HOLDINGS, LLC

Dental composite resin Dental composite resin

• Primary Device ID: D8130303819621
• NIH Device Record Key: d5b28793-2866-47ab-8451-512cf461fb58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Virtuoso®
• Version Model Number: 030381962
• Catalog Number: 030381962
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8130303819620 [Unit of Use]
HIBCC	D8130303819621 [Primary]

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Virtuoso®]

• D81338100: VISAR SEAL 10g
• D8133806B0: VISAR SEAL 4g
• D8130323818351: VIRTUOSO FLOW B1 4pc RFL KIT
• D8130323818301: VIRTUOSO FLOW A3.5 4pc RFL KIT
• D8130323818251: VIRTUOSO FLOW A3 4pc RFL KIT
• D8130323818201: VIRTUOSO FLOW A1 4pc RFL KIT
• D8130323818151: VIRTUOSO FLOW A2 4pc RFL KIT
• D8130323818100: VIRTUOSO FLOW CUSTOM REFILL KIT - 4pc
• D8130303828000: VIRTUOSO FLOWABLE INTRO KIT
• D8130303819701: VIRT UNIV B2 10pc BAGGED
• D8130303819691: VIRT UNIV A1 10pc BAGGED
• D8130303819681: VIRT UNIV A3 10pc BAGGED
• D8130303819671: VIRT UNIV B0 10pc BAGGED
• D8130303819661: VIRT UNIV B1 10pc BAGGED
• D8130303819651: VIRT UNIV C1 10pc BAGGED
• D8130303819641: VIRT UNIV C2 10pc BAGGED
• D8130303819631: VIRT UNIV A2 10pc BAGGED
• D8130303819621: VIRT UNIV ENM TRNS 10pc BAGGED
• D8130303819611: VIRT UNIV A3.5 10pc BAGGED
• D8130303819500: VIRTUOSO UNIVERSAL KIT
• D8130303818000: VIRTUOSO FLOWABLE CUSTOM KIT - 15pc
• D8130303817500: VIRTUOSO SEALANT KIT
• D8130439219010: PROTECTIVE GLASSES VIRTUOSO