Duns Number:264205501
Device Description: This is an extra- and intra-oral Sopro 617 camera designed for dental applications. It all This is an extra- and intra-oral Sopro 617 camera designed for dental applications. It allows the user to see anatomical and pathological details that cannot be seen with the naked eye, as well as pathology control and post-treatment.
Catalog Number
S_OCAM_0001
Brand Name
OWANDY
Version/Model Number
OWANDY-CAM HD PAL
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
NYH
Product Code Name
Plaque Disclosing Kit
Public Device Record Key
53958f41-f932-4e23-9862-a4e9c72aefcb
Public Version Date
January 14, 2021
Public Version Number
1
DI Record Publish Date
January 06, 2021
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 128 |