Duns Number:083235549
Device Description: FluoroPost Endodontic Fiber Posts Sample (Size #3 Blue)
Catalog Number
61I047
Brand Name
FluoroPost™ Endodontic Fiber Posts
Version/Model Number
61I047
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 28, 2019
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ELR
Product Code Name
POST, ROOT CANAL
Public Device Record Key
70b86bbc-46b0-4614-941c-0b3454c9c3b0
Public Version Date
October 03, 2022
Public Version Number
2
DI Record Publish Date
April 02, 2019
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 | 123 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 397 |
| U | Unclassified | 2 |