IVOCLAR VIVADENT AKTIENGESELLSCHAFT

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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) (6) CEMENT, DENTAL (EMA) (2) ACCESSORIES, RETRACTOR, DENTAL (EIF) (1) DISK, ABRASIVE (EHJ) (1)

Premarket Exempt

No Yes

Clear

Tetric Prime - DVIV706621US1 Catalog Number : 706621US

Device Description : Tetric PowerFlow Test Pack 1x1.3g IVA

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Tetric Prime - DVIV706622US1 Catalog Number : 706622US

Device Description : Tetric PowerFlow Test Pack 1x1.3g IVA

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Telio Desensitizer - DVIV707177AN1 Catalog Number : 707177AN

Device Description : FLK Syntac Adhesive B, FLK Syntac Adhesive B

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 2

SpeedCEM SpeedCEM Plus - DVIV710865WW1 Catalog Number : 710865WW

Device Description : Zirconia Cementation Test Kit

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Variolink Esthetic - DVIV740233WW1 Catalog Number : 740233WW

Device Description : cements

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Variolink Esthetic - DVIV740234WW1 Catalog Number : 740234WW

Device Description : cements

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

IPS Empress Direct - DVIV740800AN1 Catalog Number : 740800AN

Device Description : Empress Direct Ref. 10x0.2g A2 Enamel, Empress Direct Ref. 10x0.2g A2 Dentin, Em Empress Direct Ref. 10x0.2g A2 Enamel, Empress Direct Ref. 10x0.2g A2 Dentin, Empress Direct Ref. 10x0.2g A3 Dentin, Empress Direct Ref. 10x0.2g A3 Enamel, Empress Direct Ref. 10x0.2g Trans 30, Empress Direct Ref. 10x0.2g Opal, Empress Direct Effect Ref. 1x1.8g Opal, SPR Empress Direct Effect Color ocker, SPR Empress Direct Effect Color weiss, AdheSE Universal 0.5ml VivaPen (BULK)

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 64

OptraGate - DVIV740898WW1 Catalog Number : 740898WW

Device Description : OptraGate Small, OptraGate Regular

Device Class : 1

Duns Number: 448015938

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : Yes

Device Count : 80

OptraGloss - DVIV742102WW1 Catalog Number : 742102WW

Device Description : OptraGloss Refill Spiral Wheel HP, Instr. for use OptraGloss WW

Device Class : 1

Duns Number: 448015938

Premarket Exempt : Yes

Product Code : EHJ

Prescription Use : Yes

Device Count : 2

Tetric Prime - DVIV742319WW1 Catalog Number : 742319WW

Device Description : Tetric PrimeTetric EvoFlow Test Syringe

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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