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

POWDER, PORCELAIN (EIH) (5) Alloy, gold-based noble metal (EJT) (3) ALLOY, GOLD-BASED NOBLE METAL (EJT) (1) CEMENT, DENTAL (EMA) (1)

Premarket Exempt

No Yes

Clear

IPS e.max ZirCAD - D7077252051 Catalog Number : 725205

Device Description : IPS e.max ZirCAD Prime C3 98.5-251

Device Class : 2

Duns Number: 176935203

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

IPS e.max ZirCAD - D7077252061 Catalog Number : 725206

Device Description : IPS e.max ZirCAD Prime C4 98.5-251

Device Class : 2

Duns Number: 176935203

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

IPS e.max ZirCAD - D7077252071 Catalog Number : 725207

Device Description : IPS e.max ZirCAD Prime D2 98.5-251

Device Class : 2

Duns Number: 176935203

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

IPS e.max ZirCAD - D7077252081 Catalog Number : 725208

Device Description : IPS e.max ZirCAD Prime D3 98.5-251

Device Class : 2

Duns Number: 176935203

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

IPS e.max ZirCAD - D7077252161 Catalog Number : 725216

Device Description : IPS e.max ZirCAD Prime D4 98.5-251

Device Class : 2

Duns Number: 176935203

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

ZirCAD Cement - D707746964EN1 Catalog Number : 746964EN

Device Description : ZirCAD Cement Refill 8.5 g (US)

Device Class : 2

Duns Number: 176935203

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

585 Solder - D707NA11825040 Catalog Number : NA1182504

Device Description : .585 Fine Gold Solder 1.555g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

585 Solder - D707NA11825240 Catalog Number : NA1182524

Device Class : 2

Duns Number: 176935203

Premarket Exempt : No

Product Code : EJT

Prescription Use : Yes

Device Count : 1

615 Solder - D707NA11835040 Catalog Number : NA1183504

Device Description : .615 Fine Gold Solder

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

650 Solder - D707NA11845040 Catalog Number : NA1184504

Device Description : .650 Fine Gold Solder 1.555 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

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