Lucitone Digital Try-In™ 906221

GUDID D0019062210

Dentsply International Inc.

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

• Primary Device ID: D0019062210
• NIH Device Record Key: bc70b663-af84-441b-b674-ef030058e1ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lucitone Digital Try-In™
• Version Model Number: 3D Trial Placement Resin - A2
• Catalog Number: 906221
• 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: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0019062210 [Primary]

FDA Product Code

• EBD: Coating, filling material, resin

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 Try-In™]

• D0019062250: 3D Trial Placement Resin - BL3
• D0019062240: 3D Trial Placement Resin - B2
• D0019062230: 3D Trial Placement Resin - B1
• D0019062220: 3D Trial Placement Resin - A3
• D0019062210: 3D Trial Placement Resin - A2
• D0019062200: 3D Trial Placement Resin - A1