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

Drill, Bone, Powered (DZI) (8) Accessories, Implant, Dental, Endosseous (NDP) (2)

Premarket Exempt

Clear

CeraRoot Implant System - 08435453900317 Catalog Number : 002.003

Device Description : Twist Drill 2.8mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Ceramic.

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZI

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900324 Catalog Number : 002.004

Device Description : Twist Drill 3.5mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Ceramic.

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZI

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900331 Catalog Number : 002.005

Device Description : Twist Drill 4.2mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Ceramic.

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZI

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900348 Catalog Number : 001.006

Device Description : Drill Extender -steel

Device Class : 1

Duns Number: 467001948

Premarket Exempt : No

Product Code : NDP

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900355 Catalog Number : 001.007

Device Description : Right Angle / Handpiece Adapter 4x4 - steel

Device Class : 1

Duns Number: 467001948

Premarket Exempt : No

Product Code : NDP

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900362 Catalog Number : 003.016

Device Description : Countersink 16 - for the implant CeraRoot 16 - black color coded - steel

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZI

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900379 Catalog Number : 003.011

Device Description : Countersink 11 - for the implant CeraRoot 11 - green color coded - steel

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZI

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900386 Catalog Number : 003.021

Device Description : Countersink 21 - for the implant CeraRoot 21 - red color coded - steel

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZI

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900393 Catalog Number : 003.014

Device Description : Countersink 14 - for the implants CeraRoot 14 and the CeraRoot 34 and 34L- orang Countersink 14 - for the implants CeraRoot 14 and the CeraRoot 34 and 34L- orange and violet color coded - steel

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZI

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900409 Catalog Number : 004.016

Device Description : Countersink 16 - for the implant CeraRoot 16 - black color coded - ceramic

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZI

Prescription Use : Yes

Device Count : 1

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