3shape A/S

Address:Holmens Kanal 7,Copenhagen Hovedstaden,DK

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Device Description : The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D dig The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of the topographical characteristics of teeth from dental models and impressions – for use with CAD/CAM dental restoration design.

Device Class : 2

Duns Number: 306826012

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D dig The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of the topographical characteristics of teeth from dental models and impressions – for use with CAD/CAM dental restoration design.

Device Class : 2

Duns Number: 306826012

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D dig The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of the topographical characteristics of teeth from dental models and impressions – for use with CAD/CAM dental restoration design.

Device Class : 2

Duns Number: 306826012

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D dig The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of the topographical characteristics of teeth from dental models and impressions – for use with CAD/CAM dental restoration design.

Device Class : 2

Duns Number: 306826012

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D dig The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of the topographical characteristics of teeth from dental models and impressions – for use with CAD/CAM dental restoration design.

Device Class : 2

Duns Number: 306826012

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : 3Shape’s Ortho System™ is a software system used for the management of 3D scanne 3Shape’s Ortho System™ is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes only Export Model (also called dental casts), Custom Metal Bands (also called metal bands), and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). All devices are to be fabricated from FDA cleared materials.

Device Class : 2

Duns Number: 306826012

Premarket Exempt : No

Product Code : PNN

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D dig The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of the topographical characteristics of teeth from dental models and impressions – for use with CAD/CAM dental restoration design.

Device Class : 2

Duns Number: 306826012

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1