Duns Number:688265810
Device Description: The PROX is a hand-held diagnostic dental x-ray system. It is intended to be used by train The PROX is a hand-held diagnostic dental x-ray system. It is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source producing diagnostic X-ray images using with intra-oral image receptors. Its use is intended for adults and pediatric subjects both. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The system helps to get sharp and clear x-ray images, and its low radiation dosage keeps patients and dentists safe from leakage radiation.
Catalog Number
DPC-04
Brand Name
PROX
Version/Model Number
1
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
EHD
Product Code Name
Unit, X-Ray, Extraoral With Timer
Public Device Record Key
10d66177-1945-4841-a4c5-049f85c06df6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 07, 2016
Package DI Number
78800021800006
Quantity per Package
8
Contains DI Package
08800021800007
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Package