CERAROOT SL.

Address:Parpers 13,Les Franqueses del Valles Barcelona,ES

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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

Implant, Endosseous, Root-Form (DZE) (10)

Premarket Exempt

Clear

CeraRoot Implant System - 08435453900010 Catalog Number : 160.010

Device Description : Implant CeraRoot 16:10/4.8-6.5 Size L= 10mm Indicated for MOLARSOne-piece

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900027 Catalog Number : 160.012

Device Description : Implant CeraRoot 16:12/4.8-6.5 Size L= 12mm Indicated for MOLARSOne-piece

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900034 Catalog Number : 160.014

Device Description : Implant CeraRoot 16:14/4.8-6.5 Size L= 14mm Indicated for MOLARSOne-piece

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900041 Catalog Number : 110.010

Device Description : Implant CeraRoot 11:10/4.8-6 Size L= 10mm Indicated for WIDE CENTRAL INCI

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900058 Catalog Number : 110.012

Device Description : Implant CeraRoot 11:12/4.8-6 Size L= 12mm Indicated for WIDE CENTRAL INCI

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900065 Catalog Number : 110.014

Device Description : Implant CeraRoot 11:14/4.8-6 Size L= 14mm Indicated for WIDE CENTRAL INCI

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900072 Catalog Number : 210.010

Device Description : Implant CeraRoot 21:10/4.1-4.8 Size L= 10mm Indicated for UPPER CENTRAL I

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900089 Catalog Number : 210.012

Device Description : Implant CeraRoot 21:12/4.1-4.8 Size L= 12mm Indicated for UPPER CENTRAL I

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900096 Catalog Number : 210.014

Device Description : Implant CeraRoot 21:14/4.1-4.8 Size L= 14mm Indicated for UPPER CENTRAL I

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900102 Catalog Number : 140.008

Device Description : Implant CeraRoot 14:08/3.5-4.8 Size L= 08mm Indicated for BICUSPIDS/PREMO

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

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