Lucitone Digital Fuse™ 906185

GUDID D0019061850

Dentsply International Inc.

Dental appliance fabrication material, cured

• Primary Device ID: D0019061850
• NIH Device Record Key: 6acfb9a4-3dbb-4535-9955-15d02be226ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lucitone Digital Fuse™
• Version Model Number: Step 1 - 3D Tooth Conditioning Agent
• Catalog Number: 906185
• Company DUNS: 606173334
• Company Name: Dentsply International Inc.
• 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

Customer Support Contacts

• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com

Device Dimensions

• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0019061850 [Primary]

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: 2019-09-17
• Device Publish Date: 2019-09-09

On-Brand Devices [Lucitone Digital Fuse™]

• D0019062450: Bonding Kit
• D0019061950: Step 3 - 3D Denture Sealer
• D0019061920: Step 2 - 3D Denture Bonding Agent - Pink Opaque
• D0019061910: Step 2 - 3D Denture Bonding Agent - Pink
• D0019061900: Step 2 - 3D Denture Bonding Agent - Dark Reddish P
• D0019061890: Step 2 - 3D Denture Bonding Agent - Light Reddish
• D0019061880: Step 2 - 3D Denture Bonding Agent - Light
• D0019061870: Step 2 - 3D Denture Bonding Agent - Original Opaqu
• D0019061860: Step 2 - 3D Denture Bonding Agent - Original
• D0019061850: Step 1 - 3D Tooth Conditioning Agent