Duns Number:688379797
Device Description: EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.
Catalog Number
-
Brand Name
EzOrtho
Version/Model Number
1.2
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
K211793
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
9f097654-644c-4b19-9203-98f1904c83f6
Public Version Date
November 16, 2021
Public Version Number
1
DI Record Publish Date
November 08, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |