Calibra® Ceram Adhesive Resin Cement 607100

GUDID D0026071001

Calibra® Ceram Adhesive Resin Cement Combo Kit

DENTSPLY INTERNATIONAL INC.

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin
Primary Device IDD0026071001
NIH Device Record Key746e768e-c223-4a48-a617-778eb690967b
Commercial Distribution Discontinuation2024-06-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCalibra® Ceram Adhesive Resin Cement
Version Model Number607100
Catalog Number607100
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

Device Dimensions

Weight4.5 Gram
Device Size Text, specify0
Total Volume5 Milliliter
Weight4.5 Gram
Device Size Text, specify0
Total Volume5 Milliliter
Weight4.5 Gram
Device Size Text, specify0
Total Volume5 Milliliter
Weight4.5 Gram
Device Size Text, specify0
Total Volume5 Milliliter
Weight4.5 Gram
Device Size Text, specify0
Total Volume5 Milliliter
Weight4.5 Gram
Device Size Text, specify0
Total Volume5 Milliliter
Weight4.5 Gram
Device Size Text, specify0
Total Volume5 Milliliter
Weight4.5 Gram
Device Size Text, specify0
Total Volume5 Milliliter
Weight4.5 Gram
Device Size Text, specify0
Total Volume5 Milliliter
Weight4.5 Gram
Device Size Text, specify0
Total Volume5 Milliliter
Weight4.5 Gram
Device Size Text, specify0
Total Volume5 Milliliter
Weight4.5 Gram
Device Size Text, specify0
Total Volume5 Milliliter
Weight4.5 Gram
Device Size Text, specify0
Total Volume5 Milliliter
Weight4.5 Gram
Device Size Text, specify0
Total Volume5 Milliliter
Weight4.5 Gram
Device Size Text, specify0
Total Volume5 Milliliter
Weight4.5 Gram
Device Size Text, specify0
Total Volume5 Milliliter

Operating and Storage Conditions

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.
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
HIBCCD0026071001 [Primary]

FDA Product Code

EMACEMENT, DENTAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-06-06
Device Publish Date2016-09-21

Devices Manufactured by DENTSPLY INTERNATIONAL INC.

D0026071001 - Calibra® Ceram Adhesive Resin Cement2024-06-06Calibra® Ceram Adhesive Resin Cement Combo Kit
D0026071001 - Calibra® Ceram Adhesive Resin Cement2024-06-06 Calibra® Ceram Adhesive Resin Cement Combo Kit
D00265628302 - Dispersalloy® Dispersed Phase Alloy2024-06-06 Dispersed Phase Alloy, Fast Set Tablets, 120 tubes of 40 (389mg) tablets
D00265628612 - Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules2024-06-06 Dispersed Phase Alloy, Fast Set, 1 Spill, 500 (400mg) Green caps
D00265628622 - Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules2024-06-06 Dispersed Phase Alloy, Fast Set, 2 Spill, 500 (600mg) Blue/White caps
D00265628632 - Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules2024-06-06 Dispersed Phase Alloy, Fast Set, 3 Spill, 500 (800mg) Yellow caps
D00265628912 - Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules2024-06-06 Dispersed Phase Alloy, Regular Set, 1 Spill, 500 (400mg) Green caps
D00265628922 - Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules2024-06-06 Dispersed Phase Alloy, Regular Set, 2 Spill, 500 (600mg) Blue/White caps
D00265628932 - Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules2024-06-06 Dispersed Phase Alloy, Regular Set, 3 Spill, 500 (800mg) Yellow caps

Trademark Results [Calibra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CALIBRA
CALIBRA
98067596 not registered Live/Pending
Hamilton Associates, Inc.
2023-06-30
CALIBRA
CALIBRA
98016168 not registered Live/Pending
Calibra LLC
2023-05-26
CALIBRA
CALIBRA
90899348 not registered Live/Pending
SYNGENTA PARTICIPATIONS AG
2021-08-24
CALIBRA
CALIBRA
88479775 not registered Live/Pending
JLV, LLC
2019-06-19
CALIBRA
CALIBRA
88478791 not registered Live/Pending
Saed, Rouzin
2019-06-18
CALIBRA
CALIBRA
86583847 4877052 Live/Registered
Superabrasive
2015-04-01
CALIBRA
CALIBRA
86453026 4776258 Live/Registered
US Pharmaceutical Corporation
2014-11-13
CALIBRA
CALIBRA
86147172 not registered Dead/Abandoned
Opel Special Vehicles GmbH
2013-12-18
CALIBRA
CALIBRA
85841349 4489739 Live/Registered
MDF Instruments USA, Inc.
2013-02-05
CALIBRA
CALIBRA
85492565 not registered Dead/Abandoned
Laboratoires Goemar
2011-12-12
CALIBRA
CALIBRA
79162974 not registered Dead/Abandoned
NOVIKO Animal Health s.r.o.
2014-11-25
CALIBRA
CALIBRA
78924529 not registered Dead/Abandoned
Calibra - Companhia alimentos do BrasilS.A.
2006-07-07

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