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) (6) Laser, Fluorescence Caries Detection (NBL) (4)

Premarket Exempt

No Yes

Clear

TRIOS 5 - 05902729753739 Catalog Number :

Device Class : 2

Duns Number: 305225025

Premarket Exempt : No

Product Code : NBL

Prescription Use : Yes

Device Count : 1

TRIOS - 05902729753753 Catalog Number :

Device Class : 2

Duns Number: 305225025

Premarket Exempt : No

Product Code : NBL

Prescription Use : Yes

Device Count : 1

TRIOS - 05902729753777 Catalog Number :

Device Class : 2

Duns Number: 305225025

Premarket Exempt : No

Product Code : NBL

Prescription Use : Yes

Device Count : 1

TRIOS - 05902729753784 Catalog Number :

Device Class : 2

Duns Number: 305225025

Premarket Exempt : No

Product Code : NBL

Prescription Use : Yes

Device Count : 1

TRIOS 3 - 05902768365429 Catalog Number :

Device Description : Autoclavable scanner tip for TRIOS 3

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS 3 - 05902768365436 Catalog Number :

Device Description : Tip used for protection of the TRIOS® 3 Scanners.

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS 3 - 05902768365443 Catalog Number :

Device Description : Tip used for calibration of the TRIOS® 3 Scanner.

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS 3 - 05902768365450 Catalog Number :

Device Description : Enables TRIOS® 3 systems to measure shades.

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

TRIOS 3 - 05902768365467 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 3 - 05902768365474 Catalog Number :

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

Device Class : 2

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

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