DIOnavi-Denture02 3DDEN02-500P1

GUDID 08800049400906

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

• Primary Device ID: 08800049400906
• NIH Device Record Key: 1fb06a4f-b302-43f5-bc2e-97697ce03acc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIOnavi-Denture02
• Version Model Number: 3DDEN02-500P1
• Catalog Number: 3DDEN02-500P1
• 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	08800049400906 [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