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) (8) ALLOY, OTHER NOBLE METAL (EJS) (2)

Premarket Exempt

No Yes

Clear

Aquarius - D7075766200 Catalog Number : 576620

Device Description : Aquarius 100 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJS

Prescription Use : Yes

Device Count : 1

Academy Gold XH - D7075766210 Catalog Number : 576621

Device Description : Academy Gold XH 25 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

Sagittarius - D7075766260 Catalog Number : 576626

Device Description : Sagittarius 25 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

Sagittarius - D7075766270 Catalog Number : 576627

Device Description : Sagittarius 100 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

Minigold - D7075766280 Catalog Number : 576628

Device Description : Minigold 25 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

Maxigold - D7075766290 Catalog Number : 576629

Device Description : Maxigold 25 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

Maxigold - D7075766300 Catalog Number : 576630

Device Description : Maxigold 100 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

Maxigold KF - D7075766310 Catalog Number : 576631

Device Description : Maxigold KF 25 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

Maxigold KF - D7075766320 Catalog Number : 576632

Device Description : Maxigold KF 100 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

Lodestar - D7075766330 Catalog Number : 576633

Device Description : Lodestar 25 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJS

Prescription Use : Yes

Device Count : 1

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