DENTSPLY INTERNATIONAL INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

CEMENT, DENTAL (EMA) (8) AGENT, TOOTH BONDING, RESIN (KLE) (2)

Premarket Exempt

No Yes

Clear

Calibra® Esthetic Resin Cement - D0026070741 Catalog Number : 607074

Device Description : Calibra® Esthetic Resin Cement, Try-In Paste, Translucent, 2 (1.8g) syringe Refill Package

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 2

Calibra® Esthetic Resin Cement - D0026070751 Catalog Number : 607075

Device Description : Calibra® Esthetic Resin Cement, Try-In Paste, Opaque, 2 (1.8g) syringe Refill Package

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 2

Calibra® Esthetic Resin Cement - D0026070800 Catalog Number : 607080

Device Description : Calibra® Esthetic Resin Cement, Silane Coupling Agent, 1 (3ml) syringe Refill Package

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Calibra® Esthetic Resin Cement - D0026070810 Catalog Number : 607081

Device Description : Calibra® Esthetic Resin Cement, Dual Cure Automix, Light, 1 (4.5g) syringe Refill

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Calibra® Esthetic Resin Cement - D0026070820 Catalog Number : 607082

Device Description : Calibra® Esthetic Resin Cement, Dual Cure Automix, Medium, 1 (4.5g) syringe Refill

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Calibra® Esthetic Resin Cement - D0026070830 Catalog Number : 607083

Device Description : Calibra® Esthetic Resin Cement, Dual Cure Automix, Dark, 1 (4.5g) syringe Refill

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Calibra® Esthetic Resin Cement - D0026070840 Catalog Number : 607084

Device Description : Calibra® Esthetic Resin Cement, Dual Cure Automix, Translucent, 1 (4.5g) syringe Refill

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Calibra® Esthetic Resin Cement - D0026070850 Catalog Number : 607085

Device Description : Calibra® Esthetic Resin Cement, Dual Cure Automix, Opaque, 1 (4.5g) syringe Refill

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Calibra® Cement - D0026070861 Catalog Number : 607086

Device Description : Calibra® Cement Automix Syringe Mixing Tip Refill

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 50

Calibra® Esthetic Resin Cement - D0026070901 Catalog Number : 607090

Device Description : Calibra® Esthetic Resin Cement Veneer Kit

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

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