Vertex-Dental BV

GUDID 08720604633887

For manufacturing of 3D printed individual impression trays

Vertex-Dental B.V.

Dental impression tray material

• Primary Device ID: 08720604633887
• NIH Device Record Key: 0de2e7a8-d155-4150-b0f5-af511df78a60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vertex-Dental BV
• Version Model Number: NDTRPI01000_01
• Company DUNS: 406389056
• Company Name: Vertex-Dental B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	08720604633887 [Primary]

FDA Product Code

• EBH: MATERIAL, IMPRESSION TRAY, 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: 2024-04-29
• Device Publish Date: 2024-04-19

On-Brand Devices [Vertex-Dental BV]

• 08719425505831: Rapid Simplified 500 ML
• 08719425503585: Self Curing 25000 ml
• 08719425503578: Self Curing 200000 ml
• 08719425502021: Castavaria 200000 ml
• 08719425501666: Castavaria / 04 25000gr
• 08719425508467: NextDent C&B MFH / T1
• 08719425508450: NextDent C&B MFH / T1
• 08719425508443: NextDent C&B MFH / T1
• 08719425508436: NextDent C&B MFH / T1
• 08719425508429: NextDent C&B MFH / N3
• 08719425508412: NextDent C&B MFH / N3
• 08719425508405: NextDent C&B MFH / N3
• 08719425508399: NextDent C&B MFH / N2.5
• 08719425508382: NextDent C&B MFH / N2.5
• 08719425508375: NextDent C&B MFH / N2.5
• 08719425508368: NextDent C&B MFH / N2
• 08719425508351: NextDent C&B MFH / N2
• 08719425508344: NextDent C&B MFH / N1.5
• 08719425508337: NextDent C&B MFH / N1.5
• 08719425508320: NextDent C&B MFH / N1
• 08719425508313: NextDent C&B MFH / N1
• 08719425508306: NextDent C&B MFH / BL
• 08719425508290: NextDent C&B MFH / BL
• 08719425508283: NextDent C&B MFH / BL
• 08719425508276: NextDent C&B / A3.5
• 08719425508269: NextDent C&B / A3.5
• 08719425508252: NextDent C&B / A3.5
• 08719425508245: NextDent C&B / A3.5
• 08719425508238: NextDent C&B / A3.5
• 08719425508221: NextDent C&B / A3.5
• 08719425508214: NextDent C&B / A3.5
• 08719425508146: NextDent Ortho Clear / Clear
• 08719425508139: NextDent Ortho Clear / Clear
• 08719425508122: NextDent Ortho Clear / Clear
• 08719425508115: NextDent Ortho Clear / Clear
• 08719425508108: NextDent Ortho Clear / Clear
• 08719425503295: NextDent C&B MFH / N2
• 08719425503288: NextDent C&B MFH / N1
• 08719425503264: NextDent C&B MFH / N1.5
• 08719425501604: Cold-Curing Pour-Type Dentrue Base Material
• 08719425508597: NextDent Base / Pink
• 08719425508580: NextDent Base / Pink
• 08719425508573: NextDent Base / Pink
• 08719425508566: NextDent Base / Pink
• 08719425508559: NextDent Base / Pink
• 08719425508542: NextDent Base / Pink
• 08719425508535: NextDent Base / Pink
• 08719425508528: NextDent Base / Pink
• 08719425508511: NextDent Base / Pink
• 08719425508504: NextDent Base / Pink