Dentatus AB

Address:Finspangsgatan 42,SPANGA Stockholm,SE

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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) (6) Accessories, Implant, Dental, Endosseous (NDP) (2) Resin, Denture, Relining, Repairing, Rebasing (EBI) (2)

Premarket Exempt

No Yes

Clear

Anew Implantat System - 07350081494797 Catalog Number :

Device Description : Dentatus Anew Implant, blister pack including 1 pc

Device Class :

Duns Number: 355803412

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Anew Implant System - 07350081494803 Catalog Number :

Device Description : Dentatus Anew Implant, blister pack including 1 pc

Device Class :

Duns Number: 355803412

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Tuf-Link II - 07350081494810 Catalog Number : TK-102

Device Description : TUF-LINK 10 ml syringe Silicone Material incl. 3 mixing tips for TK-G-10 Dispenser Gun

Device Class : 2

Duns Number: 355803412

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Tuf-Link II - 07350081494827 Catalog Number : TK-502

Device Description : TUF-LINK 50 ml syringe Silicone Material incl. 10 mixing tips for TK-G Dispenser Gun.

Device Class : 2

Duns Number: 355803412

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Anew Surgical and Prosthetic Instrumentation Kit - 07350081494858 Catalog Number : SK-3

Device Description : ANEW Surgical and Prosthetic Instrumentation Kit - Drill System 22 - 1.4 Center

Device Class : 1

Duns Number: 355803412

Premarket Exempt : No

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Atlas Surgical and Prosthetic Instrumentation Kit - 07350081494872 Catalog Number : AK-3

Device Description : ATLAS Surgical and Prosthetic Instrumentation kit - Drill System 23x CePo Drills

Device Class : 1

Duns Number: 355803412

Premarket Exempt : No

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Atlas Implant System - 07350081494940 Catalog Number :

Device Description : Dentatus Atlas Implant, blister pack including 1pc

Device Class :

Duns Number: 355803412

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Atlas Implant System - 07350081494957 Catalog Number :

Device Description : Dentatus Atlas Implant, blister pack including 1 pc

Device Class :

Duns Number: 355803412

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Atlas Implant System - 07350081494964 Catalog Number :

Device Description : Dentatus Atlas Implant System, blister pack including 1 pc

Device Class :

Duns Number: 355803412

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Atlas Implant System - 07350081494971 Catalog Number :

Device Description : Dentatus Atlas Implant, blister pack including 1 pc

Device Class :

Duns Number: 355803412

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

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