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

MATERIAL, IMPRESSION (ELW) (6) Alloy, amalgam (EJJ) (4)

Premarket Exempt

No Yes

Clear

Megalloy®EZ Spherical Amalgam - D0026030061 Catalog Number : 603006

Device Description : Megalloy®EZ Spherical Amalgam Self-Activating Capsules - 10 Jars, 3 Spill (Lime Green)

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 50

Megalloy®EZ Spherical Amalgam - D0026030141 Catalog Number : 603014

Device Description : Megalloy®EZ Spherical Amalgam Self-Activating Capsules - Bulk Jars, 1 Spill Case (Red)

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 250

Megalloy®EZ Spherical Amalgam - D0026030151 Catalog Number : 603015

Device Description : Megalloy®EZ Spherical Amalgam Self-Activating Capsules - Bulk Jars, 2 Spill Case (Purple)

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 250

Megalloy®EZ Spherical Amalgam - D0026030161 Catalog Number : 603016

Device Description : Megalloy®EZ Spherical Amalgam Self-Activating Capsules - Bulk Jars, 3 Spill Cas Megalloy®EZ Spherical Amalgam Self-Activating Capsules - Bulk Jars, 3 Spill Case (Lime Green)

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 250

Jeltrate® Dustless Alginate Impression Material - D0026051001 Catalog Number : 605100

Device Description : Jeltrate® Dustless Alginate Impression Material, Regular Set, Case of 8 pouches

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 8

Jeltrate® Dustless Alginate Impression Material - D0026052001 Catalog Number : 605200

Device Description : Jeltrate® Dustless Alginate Impression Material, Fast Set, Case of 8 pouches

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 8

Jeltrate® Dustless Alginate Impression Material - D0026052201 Catalog Number : 605220

Device Description : Jeltrate® Dustless Alginate Impression Material, Fast Set, 20 pouches

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 20

Jeltrate® Dustless Alginate Impression Material - D0026052241 Catalog Number : 605224

Device Description : Jeltrate® Dustless Regular Set Pouch

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 1

Jeltrate® Dustless Alginate Impression Material, Antimicrobial - D0026055021 Catalog Number : 605502

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

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 9

Jeltrate® Plus Dustless Alginate Impression Material, Antimicrobial - D0026055030 Catalog Number : 605503

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

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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