IVOCLAR VIVADENT, INC.

Address:175 PINEVIEW DR.,AMHERST,NY,14228,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, OTHER NOBLE METAL (EJS) (6) Alloy, gold-based noble metal (EJT) (4)

Premarket Exempt

No Yes

Clear

Harmony Medium - D7075765920 Catalog Number : 576592

Device Description : Harmony Medium 25 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

Harmony KF - D7075765930 Catalog Number : 576593

Device Description : Harmony KF 25 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

d SIGN 53 - D7075765940 Catalog Number : 576594

Device Description : d.SIGN 53 25 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJS

Prescription Use : Yes

Device Count : 1

d SIGN 59 - D7075765950 Catalog Number : 576595

Device Description : d.SIGN 59 25 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJS

Prescription Use : Yes

Device Count : 1

d SIGN 67 - D7075765960 Catalog Number : 576596

Device Description : d.SIGN 67 25 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJS

Prescription Use : Yes

Device Count : 1

d SIGN 84 - D7075765970 Catalog Number : 576597

Device Description : d.SIGN 84 25 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJS

Prescription Use : Yes

Device Count : 1

Harmony XH - D7075765990 Catalog Number : 576599

Device Description : Harmony X-Hard 25 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJS

Prescription Use : Yes

Device Count : 1

Harmony PF - D7075766000 Catalog Number : 576600

Device Description : Harmony PF 25 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

d SIGN 91 - D7075766080 Catalog Number : 576608

Device Description : d.SIGN 91 25 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJS

Prescription Use : Yes

Device Count : 1

d SIGN 96 - D7075766090 Catalog Number : 576609

Device Description : d.SIGN 96 25 g

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

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