Duns Number:436664734
Device Description: Insert intended to be attached to the Mectron Ultrasonic Scaler handpieces and used for en Insert intended to be attached to the Mectron Ultrasonic Scaler handpieces and used for endodontic applications.
Catalog Number
02350001
Brand Name
MECTRON
Version/Model Number
E1
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
K140965
Product Code
ELC
Product Code Name
Scaler, Ultrasonic
Public Device Record Key
115b5d47-b751-4dec-a60d-53f39e019b04
Public Version Date
February 21, 2019
Public Version Number
4
DI Record Publish Date
August 30, 2016
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 | 45 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 199 |