NuSmile NeoMTA NMTA0.5
by Nusmile, Ltd
NuSmile NeoMTA NMTA0.5, a hygroscopic dental cement (FDA Class II; FDA product code KIF, Resin, Root Canal Filling) made by Nusmile, Ltd, was cleared under FDA 510(k) K140955 on 11 Jun 2014 and listed in FDA GUDID on 15 Feb 2017 (UDI-DI 00862487000306); the registry lists it as not in commercial distribution (GUDID) as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00862487000306 | Date15 Feb 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140955 | Date11 Jun 2014 | StatusActive |
Official records
- AccessGUDID record 00862487000306
- FDA 510(k) database K140955
Across registries
- FDA 510(k) K140955 decided 11 Jun 2014 Active
- FDA GUDID UDI-DI 00862487000306 listed 15 Feb 2017 Listed
Timeline
- Cleared FDA 510(k) K140955
- Listed FDA GUDID 00862487000306
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- NuSmile NeoMTA
- Generic name
- Hygroscopic dental cement
- Model / Ref / Catalog
- NMTA0.5
- Primary DI / UDI-DI
- 00862487000306
- 510(k) Number
- FDA product code
- KIF
- GMDN term
- Hygroscopic dental cement
- Device class
- Class II
- Regulation number
- 872.3820
- GUDID distribution status
- Not in Commercial Distribution
- Size
- Weight — 0.5 Gram
Similar devices in this category
Other devices filed under Hygroscopic dental cement.