Allcem Veneer Try-in

GUDID 07899633825776

4000055065 - ALLCEM VENEER TRY IN A2 2G CE FDA

Dentscare Ltda

Dentifrice

• Primary Device ID: 07899633825776
• NIH Device Record Key: 9aefce43-ea04-4ef3-b76f-1b9ae41fbe06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Allcem Veneer Try-in
• Version Model Number: A2 2g
• Company DUNS: 898067533
• Company Name: Dentscare Ltda
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07899633825776 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191389

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2020-06-08
• Device Publish Date: 2020-05-31

On-Brand Devices [Allcem Veneer Try-in]

• 07899633825806: 4000055059 - ALLCEM VENEER TRY IN OW 2G CE FDA
• 07899633825790: 4000055060 - ALLCEM VENEER TRY IN TRANS 2G CE FDA
• 07899633825783: 4000055057 - ALLCEM VENEER TRYIN E BLEACH M 2G CE FDA
• 07899633825776: 4000055065 - ALLCEM VENEER TRY IN A2 2G CE FDA
• 07899633825653: 4000055052 - ALLCEM VENEER TRY IN A1 2G CE FDA
• 07899633825646: 4000055051 - ALLCEM VENEER TRY IN A3 2G CE FDA