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 ® - EMICEFFUD51 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

Ena HRI ® - EMICEFFUD60 Catalog Number : EFFUD6

Device Description : Ena HRi Flow UD6 1g Light Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Ena HRI ® - EMICEFFUD61 Catalog Number : EFFUD6

Device Description : Ena HRi Flow UD6 1g Light Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Ena HRI ® - EMICEH2OA0 Catalog Number : EH2OA

Device Description : Ena HRi Enamel OA Opalescent Amber 2.5g Light Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Ena HRI ® - EMICEH2OA1 Catalog Number : EH2OA

Device Description : Ena HRi Enamel OA Opalescent Amber 2.5g Light Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Ena HRI ® - EMICEH2OBN0 Catalog Number : EH2OBN

Device Description : Ena HRi Enamel Opalescent Blue Natural OBN 2.5g Light Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Ena HRI ® - EMICEH2OBN1 Catalog Number : EH2OBN

Device Description : Ena HRi Enamel Opalescent Blue Natural OBN 2.5g Light Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Ena HRI ® - EMICEHF1N0 Catalog Number : EHF1N

Device Description : Ena HRi Stain Flow White 2gLight Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Ena HRI ® - EMICEHF1N1 Catalog Number : EHF1N

Device Description : Ena HRi Stain Flow White 2gLight Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Ena HRI ® - EMICEHF3N0 Catalog Number : EHF3N

Device Description : Ena HRi Stain Flow Blue 2gLight Curing Composite

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

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