Vertex-Dental

GUDID 08720604634112

For the manufacturing of full or partial removable denture bases

Vertex-Dental B.V.

Dental appliance fabrication material, resin

• Primary Device ID: 08720604634112
• NIH Device Record Key: f46206a3-1030-411e-823e-b4c2531a5478
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vertex-Dental
• Version Model Number: NDJTBSPI02000
• Company DUNS: 406389056
• Company Name: Vertex-Dental B.V.
• Device Count: 1
• DM Exempt: true
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• 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	08720604634112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241071

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: 2024-09-17
• Device Publish Date: 2024-09-09

On-Brand Devices [Vertex-Dental]

• 08719425509587: Ceramill Denture 3D+ / Classic Pink
• 08719425509570: NextDent Denture 3D+ / Classic Pink
• 08720604634051: For the manufacturing of full or partial removable denture bases
• 08720604634044: For the manufacturing of full or partial removable denture bases
• 08720604634037: For the manufacturing of full or partial removable denture bases
• 08720604634020: For the manufacturing of full or partial removable denture bases
• 08720604634112: For the manufacturing of full or partial removable denture bases