Duns Number:185497372
Device Description: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. Th Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Catalog Number
-
Brand Name
NuSmile NeoMTA
Version/Model Number
NMTA1.0
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
K140955
Product Code
KIF
Product Code Name
Resin, Root Canal Filling
Public Device Record Key
000951fc-ba14-45f1-8451-3ddd96f134d6
Public Version Date
September 15, 2022
Public Version Number
6
DI Record Publish Date
September 11, 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 | 1091 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |
| U | Unclassified | 1 |