Ceramill

GUDID 08719425508900

3D Print resin for the manufacturing of removable denture bases.

Vertex-Dental B.V.

Dental appliance fabrication material, cured

• Primary Device ID: 08719425508900
• NIH Device Record Key: 9807b15d-87dd-4586-be14-87912d639914
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramill
• Version Model Number: NPAGD3TP01000
• Company DUNS: 406389056
• Company Name: Vertex-Dental B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719425508900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191497

FDA Product Code

• EBI: RESIN, DENTURE, RELINING, REPAIRING, REBASING

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: 2020-07-14
• Device Publish Date: 2020-07-06

On-Brand Devices [Ceramill]

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• 08719425508900: 3D Print resin for the manufacturing of removable denture bases.
• 08719425508894: 3D Print resin for the manufacturing of removable denture bases.
• 08719425508887: 3D Print resin for the manufacturing of removable denture bases.
• 08719425508870: 3D Print resin for the manufacturing of removable denture bases.
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• 08719425508702: 3D printing material for Crown and Bridges
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• 08719425508689: 3D printing material for Crowns and Bridges
• 08719425508672: 3D printing material for Crown and Bridges
• 08719425508801: 3D printing material for digitaldigital manufacturing of splints