Lucitone 906401

GUDID D0019064010

PRIMEPRINT LUCITONE DIGITAL PRINT DENTURE BASE ORIGINAL

Dentsply International Inc.

Dental appliance fabrication material, resin

• Primary Device ID: D0019064010
• NIH Device Record Key: 693bffbe-7582-41eb-8d4c-c88dc5d2e0bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lucitone
• Version Model Number: 906401
• Catalog Number: 906401
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0019064010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231578

FDA Product Code

• KLE: AGENT, TOOTH BONDING, 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: 2023-11-22
• Device Publish Date: 2023-11-14

On-Brand Devices [Lucitone]

• D0019064130: PRIMEPRINT LUCITONE DIGITAL IPN PREMIUM TOOTH 500ML BL3
• D0019064120: PRIMEPRINT LUCITONE DIGITAL IPN PREMIUM TOOTH 500ML C1
• D0019064110: PRIMEPRINT LUCITONE DIGITAL IPN PREMIUM TOOTH 500ML B2
• D0019064100: PRIMEPRINT LUCITONE DIGITAL IPN PREMIUM TOOTH 500ML B1
• D0019064090: PRIMEPRINT LUCITONE DIGITAL IPN PREMIUM TOOTH 500ML A3.5
• D0019064080: PRIMEPRINT LUCITONE DIGITAL IPN PREMIUM TOOTH 500ML A3
• D0019064070: PRIMEPRINT LUCITONE DIGITAL IPN PREMIUM TOOTH 500ML A2
• D0019064060: PRIMEPRINT LUCITONE DIGITAL IPN PREMIUM TOOTH 500ML A1
• D0019064050: PRIMEPRINT LUCITONE DIGITAL VALUE TRIAL PLACEMENT A1
• D0019064040: PRIMEPRINT LUCITONE DIGITAL PRINT DENTURE BASE DARK REDDISH PINK
• D0019064030: PRIMEPRINT LUCITONE DIGITAL PRINT DENTURE BASE LIGHT REDDISH PINK
• D0019064020: PRIMEPRINT LUCITONE DIGITAL PRINT DENTURE BASE LIGHT
• D0019064010: PRIMEPRINT LUCITONE DIGITAL PRINT DENTURE BASE ORIGINAL
• D0019064180: Primeprint Lucitone Digital Value Trial Placement BL3
• D0019064170: Primeprint Lucitone Digital Value Trial Placement B2
• D0019064160: Primeprint Lucitone Digital Value Trial Placement B1
• D0019064150: Primeprint Lucitone Digital Value Trial Placement A3
• D0019064140: Primeprint Lucitone Digital Value Trial Placement A2