Duns Number:480420090
Device Description: EssenSeal is a permanent endodontic sealer used with obturation points (made of gutta-perc EssenSeal is a permanent endodontic sealer used with obturation points (made of gutta-percha) to seal tightly root canals. This device, a zinc oxide – eugenol based dental cement, consists of two parts, the powder and the liquid, which are mixed before use to form a paste of creamy consistency.
Catalog Number
EssenSeal
Brand Name
EssenSeal
Version/Model Number
10246
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
EMB
Product Code Name
Zinc Oxide Eugenol
Public Device Record Key
5812961b-6109-41ef-930b-41156c6fdaf8
Public Version Date
June 21, 2022
Public Version Number
1
DI Record Publish Date
June 13, 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 | 278 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |