Duns Number:481233849
Device Description: 4 bottles 300g AIR-FLOW CLASSIC powder Lemon
Catalog Number
-
Brand Name
AIR-FLOW
Version/Model Number
DV-048/A/LEM/OLD
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
K110173
Product Code
EFB
Product Code Name
Handpiece, Air-Powered, Dental
Public Device Record Key
0d5e6d84-4925-4c9b-8086-9bfe6b5a9766
Public Version Date
March 27, 2020
Public Version Number
1
DI Record Publish Date
March 19, 2020
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 |