Duns Number:480420090
Device Description: PD MTA White is a radiopaque root canal repair material material. The material composed of PD MTA White is a radiopaque root canal repair material material. The material composed of several mineral oxides is made up of thin hydrophilic particles showing the following advantages :– Optimized particle size allowing homogeneous and complete wetting during mixing– Avoids bacterial migration and penetration of tissue fluids into the root canal thanks to its excellent marginal sealing capacity– No need to dry the treated site. PD MTA White properties are not decreased in a moist environmentThe powder mixed with distilled water forms a gel, which cures in a humid environment. The material starts setting after approximately 10 minutes and the final setting time is 15 minutes. It is not necessary to wait for the final setting to continue the treatment procedure.Indications– Treatment of perforations of root canal and furcation– Treatment of internal resorption– Retrograde root canal filling after apical resection– Pulp capping– Pulpotomy– Apical plug during apexification treatment
Catalog Number
20190
Brand Name
PD MTA White
Version/Model Number
20190
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)
Yes
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
594861b6-54e9-41dc-8beb-de1fff552f93
Public Version Date
April 09, 2019
Public Version Number
3
DI Record Publish Date
April 03, 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 | 278 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |