Duns Number:241275150
Device Description: The Air-Free does not allow any air to vent out of the head of the handpiece. This willeli The Air-Free does not allow any air to vent out of the head of the handpiece. This willeliminate air sensitivity and patient discomfort during removal of bonding adhesive (i.e.Invisalign attachments); providing your patients with a pain and stress free appointment
Catalog Number
-
Brand Name
Medidenta Air Free 90 Titan
Version/Model Number
AFT90
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181691
Product Code
EFB
Product Code Name
Handpiece, Air-Powered, Dental
Public Device Record Key
7abbd420-5257-4437-a1f2-1cad843cf86b
Public Version Date
February 18, 2021
Public Version Number
1
DI Record Publish Date
February 10, 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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |