Duns Number:078474365
Device Description: EdgeSeal is a biocompatible root canal sealer for permanent sealing of root canals followi EdgeSeal is a biocompatible root canal sealer for permanent sealing of root canals following established endodontic proceduresand may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).
Catalog Number
-
Brand Name
EdgeSeal Root Canal Sealer
Version/Model Number
EESEAL
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
7b385dc0-4545-433e-baa7-d3573ef73f4a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 21, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |
| U | Unclassified | 3 |