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

Adhesive, Bracket And Tooth Conditioner, Resin (DYH) (10)

Premarket Exempt

No Yes

Clear

Ena Etch ® - EMICCOS101B0 Catalog Number : COS101B

Device Description : ENA-ETCH Etching gel 37% phosphoric acid 25ml

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Ena Etch ® - EMICCOSM1011 Catalog Number : COSM101

Device Description : ENA-ETCH Etching gel 37% phosphoric acid Kit2 x COS101 ENA-ETCH Etching gel 37% 2 ml

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Ena Etch ® - EMICCOSM101A1 Catalog Number : COSM101A

Device Description : ENA-ETCH Etching gel 37% phosphoric acid Kit4 x COS101 ENA-ETCH Etching gel 37% 2 ml

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Ena Etch ® - EMICCOSM101B1 Catalog Number : COSM101B

Device Description : ENA-ETCH Etching gel 37% phosphoric acid Kit2 x COS1011 x COS101B

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Ena Bond ® - EMICCOSM3001 Catalog Number : COSM300

Device Description : ENA-BOND ONE COMPONENT BONDING KITLight curing one component Bonding System1 COS ENA-BOND ONE COMPONENT BONDING KITLight curing one component Bonding System1 COSM300A Ena Bond Light Curing Primer (5 ml)1 COS101 Ena Etch 37% (2 ml)+ Applicators, mixing pad, tips

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Ena Bond ® - EMICCOSM300A0 Catalog Number : COSM300A

Device Description : ENA-BOND ONE COMPONENT BONDING 5ml

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Ena Bond ® - EMICCOSM300A20 Catalog Number : COSM300A2

Device Description : ENA-BOND ONE COMPONENT BONDING 2ml

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Ena Bond ® - EMICCOSM300D0 Catalog Number : COSM300D

Device Description : ENA-BOND CATALYST 5ml

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Ena Bond ® - EMICCOSM300D1 Catalog Number : COSM300D

Device Description : ENA-BOND CATALYST 5ml

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Ena Bond ® - EMICCOSM300K1 Catalog Number : COSM300K

Device Description : ENA-BOND BI COMPONENT INTRO KITEtch & Rinse Two-Component Bonding System1 COSM3 ENA-BOND BI COMPONENT INTRO KITEtch & Rinse Two-Component Bonding System1 COSM300A Ena Bond Light Curing Primer (5 ml)1 COSZ10 Ena Seal Light Curing Resin (5 ml)1 COS101 Ena Etch 37% (2 ml)+ Applicators, mixing pad, tips

Device Class : 2

Duns Number: 436661136

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

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