Integrity® Temporary Crown and Bridge Material With Fluorescence 666200

GUDID D0026662001

Integrity® Temporary Crown and Bridge Material With Fluorescence Complete Package

DENTSPLY INTERNATIONAL INC.

Temporary dental crown/bridge
Primary Device IDD0026662001
NIH Device Record Key8f73d3f7-1545-4557-8ae9-60efa7d590f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegrity® Temporary Crown and Bridge Material With Fluorescence
Version Model Number666200
Catalog Number666200
Company DUNS083235549
Company NameDENTSPLY INTERNATIONAL INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com

Device Dimensions

Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0
Weight76 Gram
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0026662001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBGCROWN AND BRIDGE, TEMPORARY, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-10-29
Device Publish Date2016-09-21

Devices Manufactured by DENTSPLY INTERNATIONAL INC.

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D0016151311 - Celtra®2024-11-18 Dentin BL2
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D0016151341 - Celtra®2024-11-18 Dentin A1
D0016151351 - Celtra®2024-11-18 Dentin A2
D0016151361 - Celtra®2024-11-18 Dentin A3
D0016151371 - Celtra®2024-11-18 Dentin A3.5
D0016151381 - Celtra®2024-11-18 Dentin A4

Trademark Results [Integrity]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTEGRITY
INTEGRITY
98493117 not registered Live/Pending
Strong Industries, Inc.
2024-04-10
INTEGRITY
INTEGRITY
98388574 not registered Live/Pending
Fusion 360 LLC
2024-02-02
INTEGRITY
INTEGRITY
98119271 not registered Live/Pending
Natare Corporation
2023-08-06
INTEGRITY
INTEGRITY
98080669 not registered Live/Pending
Integrity Marketing Group LLC
2023-07-11
INTEGRITY
INTEGRITY
97705876 not registered Live/Pending
INTEGRITY OUTDOOR LIVING CONCEPTS, LLC
2022-12-06
INTEGRITY
INTEGRITY
97303067 not registered Live/Pending
American Industrial Brands, LLC
2022-03-09
INTEGRITY
INTEGRITY
97275030 not registered Live/Pending
Laramy-K Optical, Inc.
2022-02-18
INTEGRITY
INTEGRITY
97102762 not registered Live/Pending
Granite Equity Partners, LLC
2021-11-01
INTEGRITY
INTEGRITY
90778026 not registered Live/Pending
Integrity Marketing Group, LLC
2021-06-16
INTEGRITY
INTEGRITY
90660039 not registered Live/Pending
RedZone Robotics, Inc.
2021-04-21
INTEGRITY
INTEGRITY
90485942 not registered Live/Pending
ECL Group, LLC
2021-01-25
INTEGRITY
INTEGRITY
90033347 not registered Live/Pending
RedZone Robotics, Inc.
2020-07-02
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