Duns Number:436664734
Device Description: Insert intended to be attached to the Mectron Ultrasonic Scaler handpieces and used for re Insert intended to be attached to the Mectron Ultrasonic Scaler handpieces and used for restorative applications. The package includes insert and K10 torque wrench (DI Number E32202900137).
Catalog Number
02990002-001
Brand Name
MECTRON
Version/Model Number
D2 + K10
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
1a1a57a8-2958-43d6-ad46-2ae37e360968
Public Version Date
September 19, 2019
Public Version Number
1
DI Record Publish Date
September 11, 2019
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 |