Clearance Summary
Impla-NX (Model: ISE-270M) received FDA 510(k) clearance under submission number K201192, sponsored by Micro-Nx Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2021-05-21.
- Submission: K201192
- Applicant / Sponsor: Micro-Nx Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2021-05-21
Classification & Regulation
This clearance is catalogued under FDA product code EBW and 21 CFR 872.4200, within the Dental review panel as a Class I device.