Celtra® 615132

GUDID D0016151321

Dentin BL3

Dentsply International Inc.

Dental appliance fabrication material, ceramic
Primary Device IDD0016151321
NIH Device Record Key3da6b315-f4cd-476a-bced-ca8810d19e22
Commercial Distribution StatusIn Commercial Distribution
Brand NameCeltra®
Version Model NumberCeram
Catalog Number615132
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

Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0016151321 [Primary]

FDA Product Code

EIHPOWDER, PORCELAIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-11-18
Device Publish Date2016-11-04

On-Brand Devices [Celtra®]

D0016015260Universal Stain Mahogany
D0016015250Universal Stain Olive
D0016015240Universal Stain Khaki
D0016015230Universal Stain Copper
D0016015220Universal Stain Sunset
D0016015210Universal Stain Crème
D0016015200Universal Stain White
D0016015120Universal Stain i2
D0016015110Universal Stain i1
D0016015050Universal Stain Violet
D0016015040Universal Stain 4
D0016015030Universal Stain 3
D0016015020Universal Stain 2
D0016015010Universal Stain 1
D0016015000Universal Stain 0
D0016013320Universal Overglaze
D0016016010Duo Stain & Glaze Starter Kit
D0016016000Duo Starter Kit
D0016015900Starter Kit
D0016154151CC Add-On Gingiva G5 - Mahogany
D0016154141CC Add-On Gingiva G4 - Dark
D0016154131CC Add-On Gingiva G3 - Salmon
D0016154121CC Add-On Gingiva G2 - Reddish-Pink
D0016154111CC Add-On Gingiva G1 - Pink
D0016154041CC Add-On Correction C4 - Transparent
D0016154031CC Add-On Correction C3 - Dark
D0016154021CC Add-On Correction C2 - Medium
D0016154011CC Add-On Correction C1 - Light
D0016152261CC Enamel Effect EE6 - Ivory
D0016152251CC Enamel Effect EE5 - Sky
D0016152241CC Enamel Effect EE4 - Fog
D0016152231CC Enamel Effect EE3 - Sunset
D0016152221CC Enamel Effect EE2 - Violet
D0016152211CC Enamel Effect EE1 - Sunrise
D0016152161CC Enamel Opal EO6 LT
D0016152151CC Enamel Opal EO5 HT
D0016152141CC Enamel Opal EO4 - Transparent
D0016152131CC Enamel Opal EO3 - Medium
D0016152121CC Enamel Opal EO2 - Light
D0016152111CC Enamel Opal EO1 - Extra Light
D0016152051CC Enamel E5 - White
D0016152041CC Enamel E4 - Transparent
D0016152031CC Enamel E3 - Medium
D0016152021CC Enamel E2 - Light
D0016152011CC Enamel E1 - Extra Light
D0016151861Power Dentin PD6
D0016151851Power Dentin PD5
D0016151841Power Dentin PD4
D0016151831Power Dentin PD3
D0016151821Power Dentin PD2

Trademark Results [Celtra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CELTRA
CELTRA
85883851 4453875 Live/Registered
CELTRA INC.
2013-03-22
CELTRA
CELTRA
85802001 4429974 Live/Registered
DeguDent GmbH
2012-12-13
CELTRA
CELTRA
74475791 1864614 Dead/Cancelled
Cardiac Pacemakers, Inc.
1994-01-03
CELTRA
CELTRA
74258364 not registered Dead/Abandoned
Cardiac Pacemakers, Inc.
1992-03-23

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