Lucitone Digital Try-In™ 906224

GUDID D0019062240

Dentsply International Inc.

Dental appliance fabrication material, cured
Primary Device IDD0019062240
NIH Device Record Keycce44a52-bed3-48a7-96a6-3917122578c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameLucitone Digital Try-In™
Version Model Number3D Trial Placement Resin - B2
Catalog Number906224
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

Device Dimensions

Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0019062240 [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 Date2019-09-17
Device Publish Date2019-09-09

On-Brand Devices [Lucitone Digital Try-In™]

D00190622503D Trial Placement Resin - BL3
D00190622403D Trial Placement Resin - B2
D00190622303D Trial Placement Resin - B1
D00190622203D Trial Placement Resin - A3
D00190622103D Trial Placement Resin - A2
D00190622003D Trial Placement Resin - A1

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