510(k) K181917
K181917 is an FDA 510(k) premarket notification submitted by NuSmile, Ltd. for the device "MTA2.3 MATERIALS". The FDA issued a decision of Substantially Equivalent on January 11, 2019. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. NuSmile, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 2019
- Date Received
- July 17, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resin, Root Canal Filling
- Device Class
- Class II
- Regulation Number
- 872.3820
- Review Panel
- DE
- Submission Type