Duns Number:687789453
Device Description: DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and r DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and repair of root perforation. Other indications for use include : repair of root resorption, root end filling, apexification, and pediatric pulpotomy.
Catalog Number
1003-601
Brand Name
DIA-ROOT BIO MTA
Version/Model Number
DIA-ROOT BIO MTA 0.5g
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
K200174
Product Code
KIF
Product Code Name
Resin, Root Canal Filling
Public Device Record Key
8287795d-340b-469b-8dad-3953decd5808
Public Version Date
February 04, 2021
Public Version Number
1
DI Record Publish Date
January 27, 2021
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 |