Duns Number:687789453
Device Description: A rotational device, typically made from rubber material, that is used to apply polishing A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning).
Catalog Number
950-241
Brand Name
Prophy Rubber Cup
Version/Model Number
Webbed With Washer, Latch Type
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
Yes
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
EHK
Product Code Name
Cup, Prophylaxis
Public Device Record Key
9cad6d76-c35b-47d0-b47b-8e80f1743b8c
Public Version Date
August 21, 2020
Public Version Number
1
DI Record Publish Date
August 13, 2020
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 | 4806 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 158 |