Integrity® Temporary Crown & Bridge Material With Fluorescence Cartridge System 666370

GUDID D0026663700

Integrity Temporary Crown and Bridge Material, C2, Cartridge Refill Package

DENTSPLY INTERNATIONAL INC.

Temporary dental crown/bridge
Primary Device IDD0026663700
NIH Device Record Keybe020ce8-e5df-4691-93f7-fbf1dcd85389
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegrity® Temporary Crown & Bridge Material With Fluorescence Cartridge System
Version Model Number666370
Catalog Number666370
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 Kitfalse
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

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
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
HIBCCD0026663700 [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

On-Brand Devices [Integrity® Temporary Crown & Bridge Material With Fluorescence Cartridge System]

D0026663700Integrity Temporary Crown and Bridge Material, C2, Cartridge Refill Package
D0026663600Integrity Temporary Crown and Bridge Material, A3, Cartridge Refill Package
D0026662450Integrity Temporary Crown and Bridge Material, Bleach White, Cartridge Refill Package
D0026662400Integrity Temporary Crown and Bridge Material, B1, Cartridge Refill Package
D0026662300Integrity Temporary Crown and Bridge Material, A3.5, Cartridge Refill Package
D0026662200Integrity Temporary Crown and Bridge Material, A2, Cartridge Refill Package
D0026662100Integrity Temporary Crown and Bridge Material, A1, Cartridge Refill Package

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2022-03-09
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Granite Equity Partners, LLC
2021-11-01
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2021-06-16
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2021-04-21
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2021-01-25
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RedZone Robotics, Inc.
2020-07-02
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