DENTSPLY INTERNATIONAL INC.

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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

MATERIAL, IMPRESSION (ELW) (5) CEMENT, DENTAL (EMA) (3) AGENT, TOOTH BONDING, RESIN (KLE) (2)

Premarket Exempt

No Yes

Clear

Jeltrate® Plus Dustless Alginate Impression Material, Antimicrobial - D0026055051 Catalog Number : 605505

Device Description : Jeltrate® Plus Antimicrobial Dustless Alginate Impression Material, Regular Set, Jeltrate® Plus Antimicrobial Dustless Alginate Impression Material, Regular Set, Gross Package

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 12

Jeltrate® Plus Antimicrobial Dustless Alginate Impression Material - D0026056021 Catalog Number : 605602

Device Description : Jeltrate® Plus Antimicrobial Dustless Alginate Impression Material, Fast Set, 9 can Case

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 9

Jeltrate® Plus Antimicrobial Dustless Alginate Impression Material - D0026056030 Catalog Number : 605603

Device Description : Jeltrate® Plus Antimicrobial Dustless Alginate Impression Material, Fast Set, 22 lbs Bulk

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material - D0026057001 Catalog Number : 605700

Device Description : Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material, Fast Set, Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material, Fast Set, Case of 12 pouches

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 12

Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material - D0026057101 Catalog Number : 605710

Device Description : Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material, Fast Set Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material, Fast Set Intro Kit Case

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Calibra® Esthetic Resin Cement - D0026070561 Catalog Number : 607056

Device Description : Calibra® Esthetic Resin Cement Sampler

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

Calibra® Esthetic Resin Cement - D0026070571 Catalog Number : 607057

Device Description : Calibra® Esthetic Resin Cement Trial Kit

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Calibra® Esthetic Resin Cement - D0026070581 Catalog Number : 607058

Device Description : Calibra® Esthetic Resin Cement Try-In Accessory Pack

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Calibra® Esthetic Resin Cement - D0026070591 Catalog Number : 607059

Device Description : Calibra® Esthetic Resin Cement Operatory Kit

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

Calibra® Esthetic Resin Cement - D0026070601 Catalog Number : 607060

Device Description : Calibra® Esthetic Resin Cement 2-Part Complete System Kit

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

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