Vertex-Dental BV

GUDID 08719425508504

NextDent Base / Pink

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

• Primary Device ID: 08719425508504
• NIH Device Record Key: e07613ce-547f-4fea-8b08-530e7153684e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vertex-Dental BV
• Version Model Number: NOBEBAPI00500
• Company DUNS: 406389056
• Company Name: Vertex-Dental B.V.
• Device Count: 1
• DM Exempt: false
• 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: 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	08719425508504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162572

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-11-10
• Device Publish Date: 2018-03-15

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