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 ANEW Surgical and Prosthetic Instrumentation Kit - Drill System 22 - 1.4 Center Point Pilot Drills (1 Short & 1 Long) (=1.8 Impl. Diam.) - Drill System 22 - CePo Drills for 2.2 and 2.4 Implants1 - Manual Adaptor for R/A Driver1 - Anew Chisel-End Screwcap Driver1 - R/A Hpc Driver1 - Trephine Hollow Drill1 - Sterilizable Instrumentation Kit Box1 - Instruction for use1 - X-ray template5 - Moisture Absorbing Papers

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 ATLAS Surgical and Prosthetic Instrumentation kit - Drill System 23x CePo Drills - Short (=1.8 mm implants, 2.2, 2.4 ) - Drill System 21x R/A Hpc. Implant Driver1x Manual R/A Adaptor1x Set of 3 Denture Profile Forming Instruments1x Sterilizable Instrumentation Kit Box1x Instruction for use1x X-ray template5x Moisture Absorbing Papers

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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