Allcem Core

GUDID 07899633815210

19283 - ALLCEM CORE OPAQUE PEARL - 6 GR (CE0086)

Dentscare Ltda

Dental composite resin

• Primary Device ID: 07899633815210
• NIH Device Record Key: 6eca188c-b425-4d6f-a0ee-c82d718171ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Allcem Core
• Version Model Number: Opaque Pearl 6g
• 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	07899633815210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183465

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: 2019-12-10
• Device Publish Date: 2019-12-02

On-Brand Devices [Allcem Core]

• 07899633815210: 19283 - ALLCEM CORE OPAQUE PEARL - 6 GR (CE0086)
• 07899633815203: 19282 - ALLCEM CORE A3 - 6 GR (CE0086)
• 07899633815197: 19281 - ALLCEM CORE A2 - 6 GR (CE0086)
• 07899633815180: 19280 - ALLCEM CORE A1 - 6 GR (CE0086)