IVOCLAR VIVADENT AKTIENGESELLSCHAFT

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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

MATERIAL, TOOTH SHADE, RESIN (EBF) (5) AGENT, POLISHING, ABRASIVE, ORAL CAVITY (EJR) (3) CEMENT, DENTAL (EMA) (1) DISK, ABRASIVE (EHJ) (1)

Premarket Exempt

No Yes

Clear

Telio Desensitizer - DVIV7019601 Catalog Number : 701960

Device Description : Telio Desensitizer Refill 50x0.1g

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 50

Proxyt - DVIV7032501 Catalog Number : 703250

Device Description : Proxyt fine Single Dose 200 pcs

Device Class : 1

Duns Number: 448015938

Premarket Exempt : Yes

Product Code : EJR

Prescription Use : Yes

Device Count : 200

Proxyt - DVIV7032521 Catalog Number : 703252

Device Description : Proxyt coarse Single Dose 200 pcs

Device Class : 1

Duns Number: 448015938

Premarket Exempt : Yes

Product Code : EJR

Prescription Use : Yes

Device Count : 200

Proxyt - DVIV7041131 Catalog Number : 704113

Device Description : Proxyt fine/coarse Test Pack 6 pcs

Device Class : 1

Duns Number: 448015938

Premarket Exempt : Yes

Product Code : EJR

Prescription Use : Yes

Device Count : 1

Variolink Esthetic - DVIV704794WW1 Catalog Number : 704794WW

Device Description : cements

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Variolink Esthetic - DVIV704967WW1 Catalog Number : 704967WW

Device Description : cements

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Variolink Esthetic - DVIV704969WW1 Catalog Number : 704969WW

Device Description : cements

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OPTRAGLOSS - DVIV706172WW1 Catalog Number : 706172

Device Description : OptraGloss Flame PP, OptraGloss Kelch PP, OptraGloss Linse PP, OptraGloss Flame OptraGloss Flame PP, OptraGloss Kelch PP, OptraGloss Linse PP, OptraGloss Flame HP, OptraGloss Kelch HP, OptraGloss Linse HP, OptraGloss Spiralradform HP

Device Class :

Duns Number: 448015938

Premarket Exempt : Yes

Product Code : EHJ

Prescription Use : Yes

Device Count : 7

Tetric Prime - DVIV706563US1 Catalog Number : 706563US

Device Description : Tetric Prime Refill 20x0.25g A1

Device Class :

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

Tetric Prime - DVIV706564US1 Catalog Number : 706564US

Device Description : Tetric Prime Refill 20x0.25g A2

Device Class :

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

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