Lucitone® 684309

GUDID D0016843090

Dentsply International Inc.

Dental appliance fabrication material, resin

• Primary Device ID: D0016843090
• NIH Device Record Key: a3d24ee4-07dc-4b8c-8628-72e0114f557d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lucitone®
• Version Model Number: Liquid
• Catalog Number: 684309
• Company DUNS: 606173334
• Company Name: Dentsply International Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Dimensions

• Total Volume: 430 Milliliter
• Total Volume: 430 Milliliter
• Total Volume: 430 Milliliter
• Total Volume: 430 Milliliter
• Total Volume: 430 Milliliter
• Total Volume: 430 Milliliter
• Total Volume: 430 Milliliter
• Total Volume: 430 Milliliter
• Total Volume: 430 Milliliter
• Total Volume: 430 Milliliter
• Total Volume: 430 Milliliter
• Total Volume: 430 Milliliter
• Total Volume: 430 Milliliter
• Total Volume: 430 Milliliter
• Total Volume: 430 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0016843090 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-11-10
• Device Publish Date: 2017-02-10

On-Brand Devices [Lucitone®]

• D0019060700: Clear Pour Trial Kit
• D0019059960: Blue
• D0019059950: Brown
• D0019059940: White
• D0019059930: Yellow
• D0019059920: Red
• D0019059900: Contains one (1) each of the Lucitone HIPA® Intensive Colors shades - Red, Yellow, White, Brown
• D0019059501: Clear Pour Acrylic
• D0019059300: Clear Pour Acrylic
• D0016843150: Liquid
• D0016843090: Liquid
• D0016843050: This is sold as part of the 11-Unit Packages for Lucitone 199 and Hy-Pro Lucitone. It is not sol
• D0016820220: Clear Liquid
• D0016820200: Clear Liquid
• D0016843160: 684316