Duns Number:481233849
Device Description: AIR-FLOW® handy 3.0 PERIO
Catalog Number
FT-221#NA/003
Brand Name
AIR-FLOW
Version/Model Number
A
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
K132480
Product Code
EFB
Product Code Name
Handpiece, Air-Powered, Dental
Public Device Record Key
fc1075f1-8eab-403f-98ce-f9d57d676f8f
Public Version Date
April 19, 2022
Public Version Number
1
DI Record Publish Date
April 11, 2022
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 | 226 |
2 | A medical device with a moderate to high risk that requires special controls. | 422 |
3 | A medical device with high risk that requires premarket approval | 11 |