Allcem Veneer APS 4000019285

GUDID 07899633815234

Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect veneers of up to 1.5mm of thickness, that do not have opaque infrastructure.

Dentscare Ltda

Dental composite resin

• Primary Device ID: 07899633815234
• NIH Device Record Key: f1dce209-c1ff-42e3-8f98-c906583ad114
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Allcem Veneer APS
• Version Model Number: A2 2.5g
• Catalog Number: 4000019285
• 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: false
• 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	07899633815234 [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: 2020-09-22
• Device Publish Date: 2020-09-14

On-Brand Devices [Allcem Veneer APS]

• 07899633816552: Allcem Veneer APS Mini Kit.
• 07899633815272: Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect
• 07899633815265: Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect
• 07899633815258: Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect
• 07899633815241: Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect
• 07899633815234: Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect
• 07899633815227: Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect