IVOCLAR VIVADENT, INC.

Address:1-6600 Dixie Road,Mississauga Ontario,CA

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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, gold-based noble metal (EJT) (6) ALLOY, OTHER NOBLE METAL (EJS) (3) ALLOY, METAL, BASE (EJH) (1)

Premarket Exempt

No Yes

Clear

LFWG - D707NA11856040 Catalog Number : NA1185604

Device Description : Low Fusing White Gold Solder 1.55 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

HFWG - D707NA11859040 Catalog Number : NA1185904

Device Description : High Fusing White Gold Solder

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

HFYC SDR 1 55 - D707NA11901040 Catalog Number : NA1190104

Device Description : Hi Fusing Yellow Ceramic Solder

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

HFWC Solder - D707NA11904040 Catalog Number : NA1190404

Device Description : Hi Fusing White Ceramic Solder

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

Y 2 SOLDER - D707NA11905040 Catalog Number : NA1190504

Device Description : Y-2 SOLDER 1.55

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

SHFWC - D707NA11907040 Catalog Number : NA1190704

Device Description : Special High Fusing White Ceramic Solder 1.55g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJS

Prescription Use : Yes

Device Count : 1

Super Solder - D707NA11908040 Catalog Number : NA1190804

Device Description : Super Ceramic Solder

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJS

Prescription Use : Yes

Device Count : 1

Spartan Solder - D707NA11909140 Catalog Number : NA1190914

Device Description : Spartan Ceramic Solder 1.55g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJH

Prescription Use : Yes

Device Count : 1

Golden Ceramic - D707NA11910040 Catalog Number : NA1191004

Device Description : Golden Ceramic Solder 1.55g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJS

Prescription Use : Yes

Device Count : 1

Aqaurius - D707NA11920040 Catalog Number : NA1192004

Device Description : Aquarius Ceramic Solder

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

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