ZHERMACK SPA

Address:VIA BOVAZECCHINO, 100,BADIA POLESINE (RO) Rovigo,IT

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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, IMPRESSION (ELW) (9) SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL (EID) (1)

Premarket Exempt

No Yes

Clear

zetaplus - EZHIC1006000 Catalog Number : C100600

Device Description : Condensation Silicone impression material

Device Class : 2

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

thixoflex M - EZHIC1006700 Catalog Number : C100670

Device Description : Condensation Silicone impression material

Device Class : 2

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

indurent gel - EZHIC1007000 Catalog Number : C100700

Device Description : Condensation Silicone impression material

Device Class : 2

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Occlufast Rock - EZHIC2007261 Catalog Number : C200726

Device Description : Addition silicone for Bite Registration

Device Class :

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

Colorbite D - EZHIC2007501 Catalog Number : C200750

Device Description : Addition silicone for Bite Registration

Device Class :

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

Colorbite Rock - EZHIC2007601 Catalog Number : C200760

Device Description : Addition silicone for Bite Registration

Device Class :

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

Occlufast Cad - EZHIC2008001 Catalog Number : C200800

Device Description : Addition silicone for Bite Registration

Device Class :

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

Elite HD+ Monophase Normal Set - EZHIC2020201 Catalog Number : C202020

Device Description : Addition silicone impression material

Device Class :

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

Elite HD+ Tray Material Fast Set - EZHIC2020321 Catalog Number : C202032

Device Description : Addition silicone impression material

Device Class :

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

Mixing Tips - EZHIC2020700 Catalog Number : C202070

Device Description : Mixing Tip

Device Class : 1

Duns Number: 432971034

Premarket Exempt : Yes

Product Code : EID

Prescription Use : No

Device Count : 48

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