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 System™ Software receives scan data containing topographical c The 3Shape Dental System™ Software receives scan data containing topographical characteristics of real teeth, dental impressions, or stone models. The software provides the user with the ability to create matching dental restorative prosthetics using computer aided design.The output of the device is a computer file containing the restoration(s) in digital form which can be used by 3rd party providers of milling machines and/or rapid prototyping machines to manufacture physical prosthetics. The 3Shape Dental System™ Software does not provide any means of creating physical restorations.Both “Crown and Bridge” and Customized Abutments are supported by the device as well as a number of other prosthetic types.The 3Shape Dental System™ Software can be run on properly configured “off-the-shelf” PC hardware running Microsoft® Windows and using a standard keyboard and mouse.

Device Class : 2

Duns Number: 306826012

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The Anatomy Design software is intended to be used for designing dental restorat The Anatomy Design software is intended to be used for designing dental restorations for use by dentists for patients.The Anatomy Design software can be operated by trained dental practitioners and dental technicians.The Anatomy Design software is to be used in standard dentist clinics and dental laboratories

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 : 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