MICERIUM SPA

Address:VIA G. MARCONI 83,AVEGNO Genova,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, Tooth Shade, Resin (EBF) (10)

Premarket Exempt

No Yes

Clear

Ena HRI ® - EMICEFFUD11 Catalog Number : EFFUD1

Device Description : Ena HRi Flow UD1 1g Light Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Ena HRI ® - EMICEFFUD20 Catalog Number : EFFUD2

Device Description : Ena HRi Flow UD2 1g Light Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Ena HRI ® - EMICEFFUD21 Catalog Number : EFFUD2

Device Description : Ena HRi Flow UD2 1g Light Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Ena HRI ® - EMICEFFUD30 Catalog Number : EFFUD3

Device Description : Ena HRi Flow UD3 1g Light Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Ena HRI ® - EMICEFFUD31 Catalog Number : EFFUD3

Device Description : Ena HRi Flow UD3 1g Light Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Ena HRI ® - EMICEFFUD350 Catalog Number : EFFUD3,5

Device Description : Ena HRi Flow UD3.5 1g Light Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Ena HRI ® - EMICEFFUD351 Catalog Number : EFFUD3,5

Device Description : Ena HRi Flow UD 3.5 1g Light Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Ena HRI ® - EMICEFFUD40 Catalog Number : EFFUD4

Device Description : Ena HRi Flow UD4 1g Light Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Ena HRI ® - EMICEFFUD41 Catalog Number : EFFUD4

Device Description : Ena HRi Flow UD4 1g Light Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Ena HRI ® - EMICEFFUD50 Catalog Number : EFFUD5

Device Description : Ena HRi Flow UD5 1g Light Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

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