Allcem Veneer Try-in

GUDID 07899633825783

4000055057 - ALLCEM VENEER TRYIN E BLEACH M 2G CE FDA

Dentscare Ltda

Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice

• Primary Device ID: 07899633825783
• NIH Device Record Key: c0aadf52-71fc-4647-9245-32220d303944
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Allcem Veneer Try-in
• Version Model Number: E Bleach M 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	07899633825783 [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