CERAROOT SL.

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

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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

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

Premarket Exempt

Clear

CeraRoot Implant System - 08435453900119 Catalog Number : 140.010

Device Description : Implant CeraRoot 14:10/3.5-4.8 Size L= 10mm Indicated for BICUSPIDS/PREMO Implant CeraRoot 14:10/3.5-4.8 Size L= 10mm Indicated for BICUSPIDS/PREMOLAROne-piece zirconia dental Implant including abutment.

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900126 Catalog Number : 140.012

Device Description : Implant CeraRoot 14:12/3.5-4.8 Size L= 12mm Indicated for BICUSPIDS/PREMO Implant CeraRoot 14:12/3.5-4.8 Size L= 12mm Indicated for BICUSPIDS/PREMOLAROne-piece zirconia dental Implant including abutment.

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900133 Catalog Number : 140.014

Device Description : Implant CeraRoot 14:14/3.5-4.8 Size L= 14mm Indicated for BICUSPIDS/PRE Implant CeraRoot 14:14/3.5-4.8 Size L= 14mm Indicated for BICUSPIDS/PREMOLAROne-piece zirconia dental Implant including abutment.

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900140 Catalog Number : 340.008

Device Description : Implant CeraRoot 34:8/4.1-4.8 Size L= 8mm Indicated for CANINES AND PREMO Implant CeraRoot 34:8/4.1-4.8 Size L= 8mm Indicated for CANINES AND PREMOLARS SHORT ABUTMENT 4.3MMOne-piece zirconia dental Implant including abutment.

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900157 Catalog Number : 340.010

Device Description : Implant CeraRoot 34:10/4.1-4.8 Size L= 10mm Indicated for CANINES AND PRE Implant CeraRoot 34:10/4.1-4.8 Size L= 10mm Indicated for CANINES AND PREMOLARS SHORT ABUTMENT 4.3MMOne-piece zirconia dental Implant including abutment.

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900164 Catalog Number : 340.012

Device Description : Implant CeraRoot 34:12/4.1-4.8 Size L= 12mm Indicated for CANINES AND PRE Implant CeraRoot 34:12/4.1-4.8 Size L= 12mm Indicated for CANINES AND PREMOLARS SHORT ABUTMENT 4.3MMOne-piece zirconia dental Implant including abutment.

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900171 Catalog Number : 340.014

Device Description : Implant CeraRoot 34:14/4.1-4.8 Size L= 14mm Indicated for CANINES AND PRE Implant CeraRoot 34:14/4.1-4.8 Size L= 14mm Indicated for CANINES AND PREMOLARS SHORT ABUTMENT 4.3MMOne-piece zirconia dental Implant including abutment.

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900188 Catalog Number : 341.008

Device Description : Implant CeraRoot 34:8/4.1-4.8 Size L= 8mm Indicated for CANINES AND PREM Implant CeraRoot 34:8/4.1-4.8 Size L= 8mm Indicated for CANINES AND PREMOLARS LONG ABUTMENT 5.8MMOne-piece zirconia dental Implant including abutment.

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900195 Catalog Number : 341.010

Device Description : Implant CeraRoot 34:10/4.1-4.8 Size L= 10mm Indicated for CANINES AND Implant CeraRoot 34:10/4.1-4.8 Size L= 10mm Indicated for CANINES AND PREMOLARS LONG ABUTMENT 5.8MM One-piece zirconia dental Implant including abutment.

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900201 Catalog Number : 341.012

Device Description : Implant CeraRoot 34:12/4.1-4.8 Size L= 12mm Indicated for CANINES AND PRE Implant CeraRoot 34:12/4.1-4.8 Size L= 12mm Indicated for CANINES AND PREMOLARS LONG ABUTMENT 5.8MMOne-piece zirconia dental Implant including abutment.

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

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