Lucitone Digital Fit 906112

GUDID D0019061120

Lucitone DigitalFit Denture Base Disc Original Shade – 98.5 mm / 30 mm

Dentsply International Inc.

Dental appliance fabrication material, resin
Primary Device IDD0019061120
NIH Device Record Key93484aa0-2df5-44b5-ab88-54f461edb974
Commercial Distribution StatusIn Commercial Distribution
Brand NameLucitone Digital Fit
Version Model Number906112
Catalog Number906112
Company DUNS606173334
Company NameDentsply International Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com
Phone+1(800)243-1942
Emailprosthetics-regulatory@dentsply.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0019061120 [Primary]

FDA Product Code

EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-02
Device Publish Date2024-03-25

On-Brand Devices [Lucitone Digital Fit]

D0019061370906137
D0019061360Lucitone DigitalFit Denture Base Disc Pink Shade – 98.5 mm / 30 mm
D0019061340Lucitone DigitalFit Denture Base Disc Pink Shade – 98.5 mm / 20 mm
D0019061320Lucitone DigitalFit Denture Base Disc Pink Opaque Shade – 98.5 mm / 30 mm
D0019061300Lucitone DigitalFit Denture Base Disc Pink Opaque Shade – 98.5 mm / 20 mm
D0019061290Lucitone Digital Fit Denture Base Disc Original Opaque Shade – 98.5 mm / 35 mm
D0019061280Lucitone DigitalFit Denture Base Disc Original Opaque Shade – 98.5 mm / 30 mm
D0019061270Lucitone DigitalFit Denture Base Disc Original Opaque Shade – 98.5 mm / 25 mm
D0019061260Lucitone DigitalFit Denture Base Disc Original Opaque Shade – 98.5 mm / 20 mm
D0019061250Lucitone Digital Fit Denture Base Disc Dark Pink Shade – 98.5 mm / 35 mm
D0019061240Lucitone DigitalFit Denture Base Disc Dark Pink Shade – 98.5 mm / 30 mm
D0019061230Lucitone DigitalFit Denture Base Disc Dark Pink Shade – 98.5 mm / 25 mm
D0019061220Lucitone DigitalFit Denture Base Disc Dark Pink Shade – 98.5 mm / 20 mm
D0019061210906121
D0019061190Lucitone DigitalFit Denture Base Disc Light Reddish Pink Shade – 98.5 mm / 25 mm
D0019061180Lucitone DigitalFit Denture Base Disc Light Reddish Pink Shade – 98.5 mm / 20 mm
D0019061170Lucitone Digital Fit Denture Base Disc Light Shade – 98.5 mm / 35 mm
D0019061160906116
D0019061150Lucitone DigitalFit Denture Base Disc Light Shade – 98.5 mm / 25 mm
D0019061130Lucitone Digital Fit Denture Base Disc Original Shade – 98.5 mm / 35 mm
D0019061120Lucitone DigitalFit Denture Base Disc Original Shade – 98.5 mm / 30 mm
D0019061110Lucitone DigitalFit Denture Base Disc Original Shade – 98.5 mm / 25 mm
D0019061100Lucitone Digital Fit Denture Base Disc Original Shade – 98.5 mm / 20 mm
D0019061350Lucitone DigitalFit Denture Base Disc Pink Shade – 98.5 mm / 25 mm
D0019061330Lucitone Digital Fit Denture Base Disc Pink Opaque Shade – 98.5 mm / 35 mm
D0019061310Lucitone DigitalFit Denture Base Disc Pink Opaque Shade – 98.5 mm / 25 mm
D0019061200906120
D0019061140Lucitone DigitalFit Denture Base Disc Light Shade – 98.5 mm / 20 mm

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