Mosaic 4797

GUDID 00883205104717

Mosaic Singles Opaque White 10pk

ULTRADENT PRODUCTS, INC.

Dental composite resin

• Primary Device ID: 00883205104717
• NIH Device Record Key: 2cfea07d-bb52-492c-bb48-9ab818fb0425
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mosaic
• Version Model Number: 4797
• Catalog Number: 4797
• Company DUNS: 013369913
• Company Name: ULTRADENT PRODUCTS, INC.
• 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: 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(801)572-4200
• Email: customerservice@ultradent.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205104717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151094

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Mosaic]

• 00883205104793: Mosaic Hands On Kit
• 00883205104786: Mosaic Singles Sample
• 00883205104779: Mosaic Syringe Sample
• 00883205104755: Mosaic Singles Intro Kit
• 00883205104748: Mosaic Syringe Intro Kit
• 00883205104731: Mosaic Singles A0.5 10pk
• 00883205104724: Mosaic Singles Enamel Trans 10pk
• 00883205104717: Mosaic Singles Opaque White 10pk
• 00883205104700: Mosaic Singles Enamel White 10pk
• 00883205104694: Mosaic Singles Enamel Neutral 10pk
• 00883205104687: Mosaic Singles Enamel Gray 10pk
• 00883205104670: Mosaic Singles Enamel Blush 10pk
• 00883205104663: Mosaic Singles Enamel Yellow 10pk
• 00883205104656: Mosaic Singles D2 10pk
• 00883205104649: Mosaic Singles C3 10pk
• 00883205104632: Mosaic Singles C2 10pk
• 00883205104625: Mosaic Singles B2 10pk
• 00883205104618: Mosaic Singles B1 10pk
• 00883205104601: Mosaic Singles B0.5 10pk
• 00883205104595: Mosaic Singles A5 10pk
• 00883205104588: Mosaic Singles A4 10pk
• 00883205104571: Mosaic Singles A3.5 10pk
• 00883205104564: Mosaic Singles A3 10pk
• 00883205104557: Mosaic Singles A2 10pk
• 00883205104540: Mosaic Singles A1 10pk
• 00883205104533: Mosaic Syringe Enamel Trans Refill
• 00883205104526: Mosaic Syringe Opaque White Refill
• 00883205104519: Mosaic Syringe Enamel White Refill
• 00883205104502: Mosaic Syringe Enamel Neutral Refill
• 00883205104496: Mosaic Syringe Enamel Gray Refill
• 00883205104489: Mosaic Syringe Enamel Blush Refill
• 00883205104472: Mosaic Syringe Enamel Yellow Refill
• 00883205104465: Mosaic Syringe D2 Refill
• 00883205104458: Mosaic Syringe C3 Refill
• 00883205104441: Mosaic Syringe C2 Refill
• 00883205104434: Mosaic Syringe B2 Refill
• 00883205104427: Mosaic Syringe B1 Refill
• 00883205104410: Mosaic Syringe B0.5 Refill
• 00883205104403: Mosaic Syringe A5 Refill
• 00883205104397: Mosaic Syringe A4 Refill
• 00883205104380: Mosaic Syringe A3.5 Refill
• 00883205104373: Mosaic Syringe A3 Refill
• 00883205104366: Mosaic Syringe A2 Refill
• 00883205104359: Mosaic Syringe A1 Refill
• 00883205104342: Mosaic Syringe A0.5 Refill
• 00883205028013: Mosaic Promotional Sample