Duns Number:688322841
Device Description: Metapaste Plus is a water-based calcium hydroxide paste material for root canal temporary Metapaste Plus is a water-based calcium hydroxide paste material for root canal temporary filling. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide. The state of the treatment can be confirmed by the radiopacity of barium sulfate contained. Also, it is water-soluble and easy to remove.
Catalog Number
-
Brand Name
Metapaste Plus 4.0
Version/Model Number
9485
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
-
Product Code
KIF
Product Code Name
Resin, Root Canal Filling
Public Device Record Key
5b0c7a3b-debe-48c5-9ffd-69589cedcf86
Public Version Date
October 18, 2021
Public Version Number
2
DI Record Publish Date
July 05, 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 | 1335 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 284 |