Duns Number:343831731
Device Description: Extension set ultrasonic for EndoPilot²:consisting of:Ultrasonic module,Ultrasonic handpie Extension set ultrasonic for EndoPilot²:consisting of:Ultrasonic module,Ultrasonic handpiece Newtron/ Satelec,Ultrasonic handpiece cable, Satelec, (aprox. 180cm),Rinsing adapter,Universal wrench,and a half base plate.
Catalog Number
110 3002
Brand Name
Extension set ultrasonic for EndoPilot
Version/Model Number
v01
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
K202906
Product Code
ELC
Product Code Name
Scaler, Ultrasonic
Public Device Record Key
a1ad9b2b-3af2-4529-a07d-da752896d987
Public Version Date
September 05, 2022
Public Version Number
1
DI Record Publish Date
August 26, 2022
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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 6 |