Duns Number:333710619
Device Description: The dental treatment unit running as a desktop unit is intended for use in the field of de The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation.The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
Catalog Number
M-S
Brand Name
ELECTROmatic M-S
Version/Model Number
1.012.8537
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
K163317
Product Code
EBW
Product Code Name
Controller, foot, handpiece and cord
Public Device Record Key
a48a1802-408a-4590-bdb0-810f95a6c677
Public Version Date
November 08, 2021
Public Version Number
2
DI Record Publish Date
March 01, 2021
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 | 194 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 153 |