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) (10)

Premarket Exempt

No Yes

Clear

Calibra® Esthetic Resin Cement - D0026070610 Catalog Number : 607061

Device Description : Calibra® Esthetic Resin Cement, Base, Light, 1 (2g) syringe Refill Package

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Calibra® Esthetic Resin Cement - D0026070620 Catalog Number : 607062

Device Description : Calibra® Esthetic Resin Cement, Base, Medium, 1 (2g) syringe Refill Package

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Calibra® Esthetic Resin Cement - D0026070630 Catalog Number : 607063

Device Description : Calibra® Esthetic Resin Cement, Base, Dark, 1 (2g) syringe Refill Package

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Calibra® Esthetic Resin Cement - D0026070640 Catalog Number : 607064

Device Description : Calibra® Esthetic Resin Cement, Base, Translucent, 1 (2g) syringe Refill Package

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Calibra® Esthetic Resin Cement - D0026070650 Catalog Number : 607065

Device Description : Calibra® Esthetic Resin Cement, Base, Opaque, 1 (2g) syringe Refill Page

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Calibra® Esthetic Resin Cement - D0026070680 Catalog Number : 607068

Device Description : Calibra® Esthetic Resin Cement, Catalyst, Regular Viscosity, 1 (2g) syringe Refill Package

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Calibra® Esthetic Resin Cement - D0026070690 Catalog Number : 607069

Device Description : Calibra® Esthetic Resin Cement, Catalyst, High Viscosity 1 (2g) syringe Refill Package

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Calibra® Esthetic Resin Cement - D0026070711 Catalog Number : 607071

Device Description : Calibra® Esthetic Resin Cement, Try-In Paste, Light, 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 - D0026070721 Catalog Number : 607072

Device Description : Calibra® Esthetic Resin Cement, Try-In Paste, Medium, 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 - D0026070731 Catalog Number : 607073

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

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 2

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