Duns Number:016853348
Device Description: HANDPIECE, DIRECT DRIVE, AC-POWEREDEndodontic motor with rotary and reciprocation drive, f HANDPIECE, DIRECT DRIVE, AC-POWEREDEndodontic motor with rotary and reciprocation drive, featuring a high torque brushless motor.
Catalog Number
AEU-27T
Brand Name
DENTSPLY Tulsa Dental Specialties
Version/Model Number
AEU-27T
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
June 15, 2033
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
-
Product Code
EKX
Product Code Name
Handpiece, Direct Drive, Ac-Powered
Public Device Record Key
8bbf585e-900b-48cc-b1eb-9fcbecd43355
Public Version Date
October 16, 2019
Public Version Number
3
DI Record Publish Date
June 15, 2018
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 | 21 |