Duns Number:185497372
Device Description: For use in obturating root canals as part of orthograde root canal therapy with gutta perc For use in obturating root canals as part of orthograde root canal therapy with gutta percha.
Catalog Number
-
Brand Name
Komet BioSeal Starter Kit 2.2 gm
Version/Model Number
KBCS1
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"
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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
KIF
Product Code Name
Resin, Root Canal Filling
Public Device Record Key
01abe495-d67f-4a6d-823d-ebc022b62e96
Public Version Date
September 15, 2022
Public Version Number
5
DI Record Publish Date
September 04, 2020
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 | 1091 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |
| U | Unclassified | 1 |