DMG AMERICA, LLC

Address:242 S Dean St,ENGLEWOOD,NJ,07631,US

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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

Alloy, Amalgam (EJJ) (9) Agent, Tooth Bonding, Resin (KLE) (1)

Premarket Exempt

Clear

ZenithDental - D033003619011 Catalog Number : 003-61901

Device Description : ZenithDental Etch Gel 40% Phosphoric Acid Gel (4) 1.2ml syringes

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 4

Ultra Dispersed Phase High Copper - D033099550381 Catalog Number : 099-55038

Device Description : Ultra Dispersed Phase High Copper Dental Amalgam Alloy 1 Spill Fast Set 50 jar

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 50

Ultra Dispersed Phase High Copper - D03309955038A1 Catalog Number : 099-55038A

Device Description : Ultra Dispersed Phase High Copper Dental Amalgam Alloy 1 Spill Regular Set 50 jar

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 50

Ultra Dispersed Phase High Copper - D033099550391 Catalog Number : 099-55039

Device Description : Ultra Dispersed Phase High Copper Dental Amalgam Alloy 2 Spill Fast Set 50 jar

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 50

Ultra Dispersed Phase High Copper - D03309955039A1 Catalog Number : 099-55039A

Device Description : Ultra Dispersed Phase High Copper Dental Amalgam Alloy 2 Spill Regular Set 50 jar

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 50

Ultra Dispersed Phase High Copper - D033099550441 Catalog Number : 099-55044

Device Description : Ultra Dispersed Phase High Copper Dental Amalgam Alloy 3 Spill Fast Set 50 jar

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 50

Ultra Dispersed Phase High Copper - D03309955044A1 Catalog Number : 099-55044A

Device Description : Ultra Dispersed Phase High Copper Dental Amalgam Alloy 3 Spill Regular Set 50 jar

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 50

Ultra High Copper Spherical - D033099550451 Catalog Number : 099-55045

Device Description : Ultra High Copper Spherical Dental Amalgam Alloy 1 Spill Fast Set 50 jar

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 50

Ultra High Copper Spherical - D033099550461 Catalog Number : 099-55046

Device Description : Ultra High Copper Spherical Dental Amalgam Alloy 2 Spill Fast Set 50 jar

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 50

Ultra High Copper Spherical - D033099550471 Catalog Number : 099-55047

Device Description : Ultra High Copper Spherical Dental Amalgam Alloy 3 Spill Fast Set 50 jar

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 50

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