Duns Number:265572589
Device Description: The medical device Tech in Motion® includes the following parts:• A camera to detect track 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.
Catalog Number
TIM Left-handed US
Brand Name
Tech In Motion
Version/Model Number
TIML
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NFS
Product Code Name
Device, Jaw Tracking, For Monitoring Jaw Positions
Public Device Record Key
7e742297-7b7d-441b-8dd6-c76e8ca88f53
Public Version Date
March 03, 2022
Public Version Number
1
DI Record Publish Date
February 23, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 9 |