Duns Number:315471722
Device Description: AH 26 SILVERFREE RESIN Refill is a refill item of the 2 component powder/resin root canal AH 26 SILVERFREE RESIN Refill is a refill item of the 2 component powder/resin root canal filling material containing a resin tube (D010K3019120).
Catalog Number
60620002
Brand Name
AH 26
Version/Model Number
60620002
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
-
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
ffbcdb2f-1158-44e3-99ba-7ece6318a6e1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 20, 2016
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 |