Vertex

GUDID 08720604633429

Self curing denture base material

Vertex-Dental B.V.

Dental appliance fabrication material, resin

• Primary Device ID: 08720604633429
• NIH Device Record Key: 4584a5e4-f45e-4194-9d85-128b4f82fba8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vertex
• Version Model Number: ASCP3000500
• Company DUNS: 406389056
• Company Name: Vertex-Dental B.V.
• Device Count: 1
• DM Exempt: true
• 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: 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	08720604633429 [Primary]

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: 2023-07-28
• Device Publish Date: 2023-07-20

Devices Manufactured by Vertex-Dental B.V.

• 08719425508153 - Vertex-Dental BV: 2024-10-21 NextDent Ortho Rigid / Blue
• 08719425508160 - Vertex-Dental BV: 2024-10-21 NextDent Ortho Rigid / Blue
• 08719425508177 - Vertex-Dental BV: 2024-10-21 NextDent Ortho Rigid / Blue
• 08719425508184 - Vertex-Dental BV: 2024-10-21 NextDent Ortho Rigid / Blue
• 08719425508207 - Vertex-Dental BV: 2024-10-21 NextDent Ortho Rigid / Blue
• 08719425508474 - Vertex-Dental BV: 2024-10-21 NextDent Ortho Rigid / Blue
• 08719425508801 - Ceramill: 2024-10-21 3D printing material for digitaldigital manufacturing of splints
• 08720604634129 - Vertex-Dental: 2024-10-02 For the manufacturing of full or partial removable denture bases