Duns Number:315563684
Device Description: Dental Imaging Software. Software Version 5.x.x.
Catalog Number
-
Brand Name
DBSWIN
Version/Model Number
E7200A
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
K190629
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
ebc3a1c6-e458-41e9-974d-31ce6421615d
Public Version Date
April 17, 2019
Public Version Number
1
DI Record Publish Date
April 09, 2019
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 | 24 |
2 | A medical device with a moderate to high risk that requires special controls. | 28 |