Duns Number:328971791
Device Description: Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movemen Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories
Catalog Number
NA
Brand Name
Tizian JMA Optic
Version/Model Number
01570021
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
69aff691-5756-4ac9-9361-29ec4ebcfb0d
Public Version Date
February 26, 2021
Public Version Number
1
DI Record Publish Date
February 18, 2021
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 | 18 |