Duns Number:687789453
Device Description: DIA-ROOT BIO Sealer is a MTA (mineral trioxide aggregate) based root canal sealer that pro DIA-ROOT BIO Sealer is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials.
Catalog Number
1003-701
Brand Name
DIA-ROOT BIO Sealer
Version/Model Number
DIA-ROOT BIO Sealer 2.0g
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
K200175
Product Code
KIF
Product Code Name
Resin, Root Canal Filling
Public Device Record Key
7342961e-f841-41c4-ac56-c39a5659c36b
Public Version Date
August 26, 2020
Public Version Number
1
DI Record Publish Date
August 18, 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 | 4806 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 158 |