Vertex-Dental

GUDID 08720604634037

For the manufacturing of full or partial removable denture bases

Vertex-Dental B.V.

Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin

• Primary Device ID: 08720604634037
• NIH Device Record Key: 2f736a49-b020-421f-804f-60f33c57bd8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vertex-Dental
• Version Model Number: NDBS0701000_01
• 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	08720604634037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231388

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: 2023-11-28
• Device Publish Date: 2023-11-20

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