Duns Number:119193803
Device Description: a smooth, sculpted, low-profile design to maximize patient comfort and posterior access. T a smooth, sculpted, low-profile design to maximize patient comfort and posterior access. The thin-walled, webbed cups flare consistently with moderate pressure to polish all “contours” and reach deep into interproximal spaces. Permanently sealed construction eliminates drive shaft separation. Unique lubricated gearing provides high torque and quiet dependability. Soft gray cups. Made without using natural rubber latex.
Catalog Number
70-42616
Brand Name
Contours Disposable Prophy Angles Soft Cup
Version/Model Number
70-42616
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
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
ad87bcc2-b4bd-47be-a877-8875b1dc233d
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896010037
Quantity per Package
12
Contains DI Package
00723896010020
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |