3shape Trios A/S

Address:Holmens Kanal 7,copenhagen Hovedstaden,DK

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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

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations (NOF) (10)

Premarket Exempt

No Yes

Clear

TRIOS® 3 - 05902729750127 Catalog Number :

Device Description : Scanner tip w. mirror (autoclavable)

Device Class :

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS® 3 - 05902729750387 Catalog Number :

Device Description : Intraoral digital impression system for CAD/CAM Cart with Wireless color handle- Intraoral digital impression system for CAD/CAM Cart with Wireless color handle-grip scanner

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS® 3 - 05902729750394 Catalog Number :

Device Description : Intraoral digital impression system for CAD/CAM Battery cart with Wireless color Intraoral digital impression system for CAD/CAM Battery cart with Wireless color handle-grip scanner

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS® 3 - 05902729750400 Catalog Number :

Device Description : Intraoral digital impression system for CAD/CAM Pod with Wireless color handle-g Intraoral digital impression system for CAD/CAM Pod with Wireless color handle-grip scanner

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS® 3 - 05902729750745 Catalog Number :

Device Description : Pod-stand for handle-grip configuration

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS® 3 - 05902729750752 Catalog Number :

Device Description : Wireless color handle-grip intraoral scanner w. protection tip

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS® 3 - 05902729750769 Catalog Number :

Device Description : Wireless mono handle-grip intraoral scanner w. protection tip

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS® - 05902729750776 Catalog Number :

Device Description : Battery charger for handle-grip batteries

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS® - 05902729750783 Catalog Number :

Device Description : Rechargeable handle-grip battery

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

3Shape - 05902729750790 Catalog Number :

Device Description : Demo model Advanced

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

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