Duns Number:688731057
Device Description: SmartMTA is an ideal material for vital pulp therapy and root repair. With a setting time SmartMTA is an ideal material for vital pulp therapy and root repair. With a setting time of 150 seconds and no washout, it is ideal for one-visit treatment. SmartMTA contains no heavy metals and will not discolor after application. SmartMTA has a wide variety of clinical indications such as partial and complete pulpotomy for deciduous teeth, direct and indirect pulp capping, base formation, root repair and prevention of discoloration when used for tooth whitening procedures.
Catalog Number
-
Brand Name
Smart MTA
Version/Model Number
SmMTA-10
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132825
Product Code
KIF
Product Code Name
Resin, Root Canal Filling
Public Device Record Key
8248c305-0f14-46bb-926e-73df994fd504
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 13, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |