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

Varnish, Cavity (LBH) (4) Alloy, Amalgam (EJJ) (3) Coating, Filling Material, Resin (EBD) (2) Material, Tooth Shade, Resin (EBF) (1)

Premarket Exempt

Clear

ZenithDental Royale Dispersed Phase High Copper - D033099651031 Catalog Number : 099-65103

Device Description : ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 1 Spill Fas ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 1 Spill Fast Set 100 jar

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 100

ZenithDental Royale Dispersed Phase High Copper - D033099651041 Catalog Number : 099-65104

Device Description : ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 2 Spill Fas ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 2 Spill Fast Set 100 jar

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 100

ZenithDental Royale Dispersed Phase High Copper - D033099651051 Catalog Number : 099-65105

Device Description : ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 3 Spill Fas ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 3 Spill Fast Set 100 jar

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 100

ZenithDenatl - D033610501 Catalog Number : 003-61050

Device Description : ZenithDental Natural Cure Composite 1-14g base, 1-14g Catalyst with mixing pads ZenithDental Natural Cure Composite 1-14g base, 1-14g Catalyst with mixing pads and spatulas

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : EBD

Prescription Use : No

Device Count : 2

ZenithDental - D033610551 Catalog Number : 003-61055

Device Description : ZenithDental Core Material 1-14g base, 1-14g Catalyst and mising pads/spatulas

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : EBD

Prescription Use : No

Device Count : 2

ZenithDental - D033611811 Catalog Number : 003-61181

Device Description : ZenithDental Anterior/Posterior Hybrid Visible Light Cured Universal (u)

Device Class : 2

Duns Number: 106792427

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

KOLORZ - D0337955161 Catalog Number : 799516

Device Description : KOLORZ CLEARSHIELD 5% NAF VARNISH WHITE Caramel 35 PACK

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 35

KOLORZ - D0337995011 Catalog Number : 799501

Device Description : KOLORZ CLEARSHIELD 5% NAF VARNISH WHITE WATERMELON 35 PACK

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 35

KOLORZ - D0337995021 Catalog Number : 799502

Device Description : KOLORZ CLEAR SHIELD 5% NAF VARNISH WHITE WATERMELON 200 PACK

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 200

KOLORZ - D0337995031 Catalog Number : 799503

Device Description : KOLORZ CLEARSHIELD 5% NAF VARNISH WHITE BUBBLEGUM 35 PACK

Device Class :

Duns Number: 106792427

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 35

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