NextDent

GUDID 08719425509198

3D Print resin for the manufacturing of removable denture bases.

Vertex-Dental B.V.

Dental appliance fabrication material, cured

• Primary Device ID: 08719425509198
• NIH Device Record Key: 859184df-f584-4a4f-9b2a-0d3a973ff37d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NextDent
• Version Model Number: NDD3TP01000_1
• Company DUNS: 406389056
• Company Name: Vertex-Dental B.V.
• Device Count: 1
• DM Exempt: false
• 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: 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	08719425509198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191497

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: 2020-07-14
• Device Publish Date: 2020-07-06

On-Brand Devices [NextDent ]

• 08719425509198: 3D Print resin for the manufacturing of removable denture bases.
• 08719425509181: 3D Print resin for the manufacturing of removable denture bases.
• 08719425509174: 3D Print resin for the manufacturing of removable denture bases.
• 08719425509167: 3D Print resin for the manufacturing of removable denture bases.
• 08719425509150: 3D Print resin for the manufacturing of removable denture bases.
• 08719425509556: NextDent Ortho Flex
• 08720604633733: 3D Print resin for the manufacturing of removable denture bases
• 08720604633726: 3D Print resin for the manufacturing of removable denture bases
• 08720604633719: 3D Print resin for the manufacturing of removable denture bases
• 08720604633696: 3D Print resin for the manufacturing of removable denture bases
• 08720604633689: 3D Print resin for the manufacturing of removable denture bases
• 08720604633658: 3D Print resin for the manufacturing of removable denture bases