Celtra® Ceram 615717

GUDID D0016157171

Dentsply International Inc.

Dental appliance fabrication material, ceramic
Primary Device IDD0016157171
NIH Device Record Key00042d0e-e220-45f1-841e-624497dc098d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCeltra® Ceram
Version Model NumberDentin 418
Catalog Number615717
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 Datefalse
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

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0016157171 [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 Number2
Public Version Date2024-11-18
Device Publish Date2019-03-15

On-Brand Devices [Celtra® Ceram]

D0016507251Dentin 526
D0016507241Dentin 525
D0016507231Dentin 524
D0016507221Dentin 423
D0016507211Dentin 422
D0016507201Dentin 421
D0016507191Dentin 420
D0016507181Dentin 419
D0016507171Dentin 418
D0016507161Dentin 417
D0016507151Dentin 316
D0016507141Dentin 315
D0016507131Dentin 314
D0016507121Dentin 313
D0016507111Dentin 312
D0016507101Dentin 311
D0016507091Dentin 310
D0016507081Dentin 209
D0016507071Dentin 208
D0016507061Dentin 207
D0016507051Dentin 206
D0016507041Dentin 205
D0016507031Dentin 204
D0016507021Dentin 203
D0016507011Dentin 102
D0016507001Dentin 101
D0016157251Dentin 526
D0016157241Dentin 525
D0016157231Dentin 524
D0016157221Dentin 423
D0016157211Dentin 422
D0016157201Dentin 421
D0016157191Dentin 420
D0016157181Dentin 419
D0016157171Dentin 418
D0016157161Dentin 417
D0016157141Dentin 315
D0016157131Dentin 314
D0016157121Dentin 313
D0016157111Dentin 312
D0016157101Dentin 311
D0016157091Dentin 310
D0016157081Dentin 209
D0016157071Dentin 208
D0016157061Dentin 207
D0016157051Dentin 206
D0016157041Dentin 205
D0016157031Dentin 204
D0016157021Dentin 203
D0016157011Dentin 102

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.