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) (10)

Premarket Exempt

No Yes

Clear

hydrogum 5 - EZHIC3020750 Catalog Number : C302075

Device Description : Alginate impression material

Device Class : 2

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

orthoprint - EZHIC3021450 Catalog Number : C302145

Device Description : Alginate impression material

Device Class : 2

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

orthoprint - EZHIC3021601 Catalog Number : C302160

Device Description : Alginate impression material

Device Class : 2

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

orthoprint - EZHIC3021611 Catalog Number : C302161

Device Description : Alginate impression material

Device Class :

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

orthoprint - EZHIC3021710 Catalog Number : C302171

Device Description : Alginate impression material

Device Class : 2

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

neocolloid - EZHIC3022050 Catalog Number : C302205

Device Description : Alginate impression material

Device Class : 2

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

tropicalgin - EZHIC3022400 Catalog Number : C302240

Device Description : Alginate impression material

Device Class : 2

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

tropicalgin - EZHIC3022411 Catalog Number : C302241

Device Description : Alginate impression material

Device Class : 2

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

tropicalgin - EZHIC3022421 Catalog Number : C302242

Device Description : Alginate impression material

Device Class :

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

tropicalgin - EZHIC3022450 Catalog Number : C302245

Device Description : Alginate impression material

Device Class : 2

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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