Duns Number:557804458
Device Description: EzSensor Soft is a modern digital imaging solution for intraoral dental radiography. Its a EzSensor Soft is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy
Catalog Number
-
Brand Name
EzSensor Soft 2.0
Version/Model Number
EzSensor Soft i 2.0
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
MUH
Product Code Name
System,X-Ray,Extraoral Source,Digital
Public Device Record Key
b4fee91f-2abf-4446-90e3-e4fa7ea6091c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 2016
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 110 |