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 - 05902768365580 Catalog Number :

Device Description : Calibaration kit for TRIOS Color to measure shades

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS - 05902768365597 Catalog Number :

Device Description : handheld 3D scanner with handle for intraoral scanning.

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS - 05902768365672 Catalog Number :

Device Description : Tip used for protection of TRIOS Color and TRIOS Standard Scanners

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS® - 05902768365771 Catalog Number :

Device Description : Monochrome 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 - 05902768365788 Catalog Number :

Device Description : Monochrome pen-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 - 05902768365795 Catalog Number :

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

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS® 3 - 05902768365801 Catalog Number :

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

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS® 3 - 05902768365818 Catalog Number :

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

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS® 3 - 05902768365825 Catalog Number :

Device Description : Intraoral digital impression system for CAD/CAM Cart with Monochrome pen-grip scanner

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS® 3 - 05902768365856 Catalog Number :

Device Description : Intraoral digital impression system for CAD/CAMPod with handle-grip scanner

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

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