Duns Number:041863955
Device Description: The XZeal Z70 Wall is an XRay source to produce intraoral images for the diagnosis of tee The XZeal Z70 Wall is an XRay source to produce intraoral images for the diagnosis of teeath and adjacent structures.
Catalog Number
XZ013
Brand Name
XZeal Z70 Wall
Version/Model Number
Large Arm
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
K122582
Product Code
EHD
Product Code Name
Unit, X-Ray, Extraoral With Timer
Public Device Record Key
8326a5d6-9333-4038-8ed1-93aa62e11df0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 27, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |