Duns Number:433051802
Device Description: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-MIND unity is anextra-oral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment ofdisease of the teeth, jaw and oral structures.
Catalog Number
W0800002
Brand Name
X-MIND unity
Version/Model Number
XMU TOP 110 SHORT CONE
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
K132378
Product Code
EHD
Product Code Name
Unit, X-Ray, Extraoral With Timer
Public Device Record Key
fdbce3c4-21d8-4454-a7d0-6f8f3d328797
Public Version Date
August 06, 2018
Public Version Number
4
DI Record Publish Date
September 01, 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. | 63 |