Duns Number:381582196
Device Description: Adaptable handpiece for either SUPRA and SUB-gingival treatments4 AIR-N-GO® nozzles for pe Adaptable handpiece for either SUPRA and SUB-gingival treatments4 AIR-N-GO® nozzles for perfect removal of pathogenic bacteriaComplete range of powders to provide customized solutions for all clinical needsGentle and efficient treatments for better patient comfort
Catalog Number
F10132
Brand Name
ACTEON
Version/Model Number
AIR N GO EASY WH x 2BUSES
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
K110379
Product Code
EFB
Product Code Name
Handpiece, Air-Powered, Dental
Public Device Record Key
cf19a39b-a109-4ab0-a911-5d54c2b3cdd0
Public Version Date
December 31, 2019
Public Version Number
1
DI Record Publish Date
December 23, 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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 416 |