Address:11-13 Avenue Albert Einstein,VILLEURBANNE Rhone,FR
Device Description : The medical device Tech in Motion® includes the following parts:• A camera to de The medical device Tech in Motion® includes the following parts:• A camera to detect trackers positions through infra-red emission. • A specific software solution installed on a touchscreen PC that allows the visualisation of 3D dental models in motion.• A set of trackers intended to be placed on the patient’s head and in patient’s mouth.• A pen tracker used by the dentist to acquire trackers positions (infrared communication to the camera then transferred to a dedicated software). • An operational cart designed to hold and position the camera and the touchscreen panel PC. The camera is mounted on the cart in left-handed configurations.
Device Class : 1
Duns Number: 265572589
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The medical device Tech in Motion® includes the following parts:• A camera to de The medical device Tech in Motion® includes the following parts:• A camera to detect trackers positions through infra-red emission. • A specific software solution installed on a touchscreen PC that allows the visualisation of 3D dental models in motion.• A set of trackers intended to be placed on the patient’s head and in patient’s mouth.• A pen tracker used by the dentist to acquire trackers positions (infrared communication to the camera then transferred to a dedicated software). • An operational cart designed to hold and position the camera and the touchscreen panel PC. The camera is mounted on the cart in right-handed configurations.
Device Class : 1
Duns Number: 265572589
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Fiducials are the reflective targets fixed on the different trackers (pen, front Fiducials are the reflective targets fixed on the different trackers (pen, frontal, mandible) and should reflect infra-red light with required intensity.
Device Class : 1
Duns Number: 265572589
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Single-use support for the SMILIT mandibular tracker, which is fixed to the pati Single-use support for the SMILIT mandibular tracker, which is fixed to the patient's teeth.
Device Class : 1
Duns Number: 265572589
Premarket Exempt : Yes
Prescription Use : Yes
Device Class : 1
Duns Number: 265572589
Premarket Exempt : Yes
Prescription Use : Yes
Device Class : 1
Duns Number: 265572589
Premarket Exempt : Yes
Prescription Use : Yes
Device Class : 1
Duns Number: 265572589
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The pen is used in order to collect positioning of reference points in space.The The pen is used in order to collect positioning of reference points in space.The pen is used to calibrate the precision of the device.
Device Class : 1
Duns Number: 265572589
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A set of trackers intended to be placed on the patient’s head and in patient’s m A set of trackers intended to be placed on the patient’s head and in patient’s mouth including :- Mandibular tracker - Frontal tracker- pen tracker
Device Class : 1
Duns Number: 265572589
Premarket Exempt : Yes
Prescription Use : Yes