DIOnavi-Denture02 3DDEN02-100A4

GUDID 08800049401842

DIOnavi-Denture02 is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with DIOnavi-Denture02 requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, a digital light processing(DLP) printer, and curing light equipment.

DIO Corporation

Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured 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 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: 08800049401842
• NIH Device Record Key: 234844a9-386a-4f49-bac9-10b1da7039e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIOnavi-Denture02
• Version Model Number: 3DDEN02-100A4
• Catalog Number: 3DDEN02-100A4
• Company DUNS: 631085206
• Company Name: DIO Corporation
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800049401842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210828

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: 2021-05-19
• Device Publish Date: 2021-05-11

On-Brand Devices [DIOnavi-Denture02]

• 08806169099501: DIOnavi-Denture02 is a light-curable resin indicated for fabrication and repair of full and part
• 08800049401842: DIOnavi-Denture02 is a light-curable resin indicated for fabrication and repair of full and part
• 08800049400906: DIOnavi-Denture02 is a light-curable resin indicated for fabrication and repair of full and part
• 08800049400890: DIOnavi-Denture02 is a light-curable resin indicated for fabrication and repair of full and part