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) (8) SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL (EID) (2)

Premarket Exempt

No Yes

Clear

Elite HD+ Putty Soft Fast Set - EZHIC2030100 Catalog Number : C203010

Device Description : Addition silicone impression material

Device Class : 2

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Elite HD+ Putty Soft Fast Set - EZHIC2030121 Catalog Number : C203012

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+ Regular Body Normal Set - EZHIC2030201 Catalog Number : C203020

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+ Regular Body Normal Set - EZHIC2030250 Catalog Number : C203025

Device Description : Addition silicone impression material

Device Class : 2

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Elite HD+ Light Body Normal Set - EZHIC2030301 Catalog Number : C203030

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+ Light Body Normal Set - EZHIC2030350 Catalog Number : C203035

Device Description : Addition silicone impression material

Device Class : 2

Duns Number: 432971034

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Elite HD+ Light Body Fast Set - EZHIC2030401 Catalog Number : C203040

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+ Super Light Body Fast Set - EZHIC2030501 Catalog Number : C203050

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 - EZHIC2032330 Catalog Number : C203233

Device Description : Mixing Tip

Device Class : 1

Duns Number: 432971034

Premarket Exempt : Yes

Product Code : EID

Prescription Use : No

Device Count : 48

Mixing Tips - EZHIC2055000 Catalog Number : C205500

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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