Calibra® Bio 607600

GUDID D0026076000

Calibra® Bio Evaluator Kit

DENTSPLY INTERNATIONAL INC.

Glass ionomer dental cement

Primary Device ID	D0026076000
NIH Device Record Key	e2aad992-ef3d-49db-825f-bad9700cc638
Commercial Distribution Status	In Commercial Distribution
Brand Name	Calibra® Bio
Version Model Number	607600
Catalog Number	607600
Company DUNS	083235549
Company Name	DENTSPLY INTERNATIONAL INC.
Device Count	5
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com
Phone	+1(800)532-2855
Email	MilfordDE-Customer-Service@dentsplysirona.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.
Storage Environment Temperature	Between 4 Degrees Celsius and 20 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Protect from moisture.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0026076000 [Unit of Use]
HIBCC	D0026076001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K113040

FDA Product Code

EMA	CEMENT, DENTAL

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-09-01
Device Publish Date	2022-08-24

Devices Manufactured by DENTSPLY INTERNATIONAL INC.

D0029444001 - SmartLite® Pro Modular LED Curing Light	2025-09-17
D0019064140 - Lucitone	2025-07-09 Primeprint Lucitone Digital Value Trial Placement A2
D0019064150 - Lucitone	2025-07-09 Primeprint Lucitone Digital Value Trial Placement A3
D0019064160 - Lucitone	2025-07-09 Primeprint Lucitone Digital Value Trial Placement B1
D0019064170 - Lucitone	2025-07-09 Primeprint Lucitone Digital Value Trial Placement B2
D0019064180 - Lucitone	2025-07-09 Primeprint Lucitone Digital Value Trial Placement BL3
D0016055400 - DENTSPLY Sirona®	2025-03-31 Overglaze
D0016055421 - DENTSPLY Sirona®	2025-03-25 Overglaze High Flu

Trademark Results [Calibra]

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