AMD Medicom Inc

Address:2555 Chemin de l'Aviation,Pointe-Claire, Montreal Quebec,CA

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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

Premarket Exempt

No Yes

Clear

Elements by Hedy - D903HEVPSHR1 Catalog Number : HE-VPSHR

Device Description : Dental Impression Material - Elements VPS Heavy Body Reg-Set Kit

Device Class :

Duns Number: 256880576

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Elements by Hedy - D903HEVPSLF1 Catalog Number : HE-VPSLF

Device Description : Dental Impression Material - Elements VPS Light Body Fast-Set Kit

Device Class :

Duns Number: 256880576

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Elements by Hedy - D903HEVPSLR1 Catalog Number : HE-VPSLR

Device Description : Dental Impression Material - Elements VPS Light Body Reg-Set Kit

Device Class :

Duns Number: 256880576

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Elements by Hedy - D903HEVPSMF1 Catalog Number : HE-VPSMF

Device Description : Dental Impression Material - Elements VPS Medium Body Fast-Set Kit

Device Class :

Duns Number: 256880576

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Elements by Hedy - D903HEVPSMNF1 Catalog Number : HE-VPSMNF

Device Description : Dental Impression Material - Elements VPS MONO. Body Fast-Set Kit

Device Class :

Duns Number: 256880576

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Elements by Hedy - D903HEVPSMNR1 Catalog Number : HE-VPSMNR

Device Description : Dental Impression Material - Elements VPS MONO. Body Reg-Set Kit

Device Class :

Duns Number: 256880576

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Elements by Hedy - D903HEVPSMR1 Catalog Number : HE-VPSMR

Device Description : Dental Impression Material - Elements VPS Medium Body Reg-Set Kit

Device Class :

Duns Number: 256880576

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

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