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

Drill, Bone, Powered (DZI) (6) Implant, Endosseous, Root-Form (DZE) (4)

Premarket Exempt

Clear

CeraRoot Implant System - 08435453900218 Catalog Number : 341.014

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 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 - 08435453900225 Catalog Number : 120.010

Device Description : Implant CeraRoot 12:10/4.1 Size L= 10mm Indicated for UPPER LATERAL INCIS Implant CeraRoot 12:10/4.1 Size L= 10mm Indicated for UPPER LATERAL INCISORS AND LOWER INCISORSOne-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 - 08435453900232 Catalog Number : 120.012

Device Description : Implant CeraRoot 12:12/4.1 Size L= 12mm Indicated for UPPER LATERAL INCIS Implant CeraRoot 12:12/4.1 Size L= 12mm Indicated for UPPER LATERAL INCISORS AND LOWER INCISORSOne-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 - 08435453900249 Catalog Number : 120.014

Device Description : Implant CeraRoot 12:14/4.1 Size L= 14mm Indicated for UPPER LATERAL INCIS Implant CeraRoot 12:14/4.1 Size L= 14mm Indicated for UPPER LATERAL INCISORS AND LOWER INCISORSOne-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 - 08435453900256 Catalog Number : 001.001

Device Description : Twist Drill Triangle Shape to start osteotomy, with laser marks at 6-8-10-12-14- Twist Drill Triangle Shape to start osteotomy, with laser marks at 6-8-10-12-14-16mm. Made of Steel.

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZI

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900263 Catalog Number : 001.002

Device Description : Twist Drill 2.3mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Steel.

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZI

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900270 Catalog Number : 001.003

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

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZI

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900287 Catalog Number : 001.004

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

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZI

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900294 Catalog Number : 001.005

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

Device Class : 2

Duns Number: 467001948

Premarket Exempt : No

Product Code : DZI

Prescription Use : Yes

Device Count : 1

CeraRoot Implant System - 08435453900300 Catalog Number : 002.002

Device Description : Twist Drill 2.3mm 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

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