Duns Number:368444471
Device Description: DC-Air™ Intraoral Sensor is intended for radiographic examination to assist with diagnosis DC-Air™ Intraoral Sensor is intended for radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure. The sensor is intended to capture an intraoral x-ray image, when exposed to x-rays, for dental diagnostic purposes.
Catalog Number
-
Brand Name
DC-Air™ Intraoral Sensor
Version/Model Number
WIOS-S2
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
K211688,K211688
Product Code
MUH
Product Code Name
System, X-Ray, Extraoral Source, Digital
Public Device Record Key
5a53ab25-a405-47c2-b4c8-856cb8b095bf
Public Version Date
May 03, 2022
Public Version Number
2
DI Record Publish Date
March 10, 2022
Package DI Number
06429810587060
Quantity per Package
1
Contains DI Package
06429810587008
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |