Duns Number:315471722
Device Description: Mixing Tip/ Intraoral Tip is the mixing and application device to be applied with AH Plus Mixing Tip/ Intraoral Tip is the mixing and application device to be applied with AH Plus Jet and is available seperately
Catalog Number
60620116
Brand Name
Mixint Tip / Intraoral Tip
Version/Model Number
60620116
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"
-
For Single-Use
Yes
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
KIF
Product Code Name
RESIN, ROOT CANAL FILLING
Public Device Record Key
e35c5acd-b4c5-46bc-a703-965dff9633fe
Public Version Date
December 24, 2020
Public Version Number
1
DI Record Publish Date
December 16, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |