Lucitone Digital Fuse™ 906195

GUDID D0019061950

Dentsply International Inc.

Dental appliance fabrication material, cured
Primary Device IDD0019061950
NIH Device Record Key73b32eae-fca1-415c-92bc-9b2ed8a0e4e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameLucitone Digital Fuse™
Version Model NumberStep 3 - 3D Denture Sealer
Catalog Number906195
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regulatory@dentsplysirona.com

Device Dimensions

Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0019061950 [Primary]

FDA Product Code

EBDCoating, filling material, resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-17
Device Publish Date2019-09-09

On-Brand Devices [Lucitone Digital Fuse™]

D0019062450Bonding Kit
D0019061950Step 3 - 3D Denture Sealer
D0019061920Step 2 - 3D Denture Bonding Agent - Pink Opaque
D0019061910Step 2 - 3D Denture Bonding Agent - Pink
D0019061900Step 2 - 3D Denture Bonding Agent - Dark Reddish P
D0019061890Step 2 - 3D Denture Bonding Agent - Light Reddish
D0019061880Step 2 - 3D Denture Bonding Agent - Light
D0019061870Step 2 - 3D Denture Bonding Agent - Original Opaqu
D0019061860Step 2 - 3D Denture Bonding Agent - Original
D0019061850Step 1 - 3D Tooth Conditioning Agent

Trademark Results [Lucitone Digital Fuse]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LUCITONE DIGITAL FUSE
LUCITONE DIGITAL FUSE
90747320 not registered Live/Pending
Dentsply Sirona Inc.
2021-06-01

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