Duns Number:942778564
Device Description: AH Plus Bioceramic Sealer Refill Syringe
Catalog Number
AHPBIOREFILL
Brand Name
AH Plus BioCermanic Sealer
Version/Model Number
AHPBIOREFILL
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
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
39fa5897-e264-4ce0-be58-620ce069bbab
Public Version Date
August 25, 2022
Public Version Number
1
DI Record Publish Date
August 17, 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 | 1973 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |
| U | Unclassified | 16 |