Clearance Summary
ENDO SMART received FDA 510(k) clearance under submission number K133298, sponsored by Meta Biomed, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2014-09-19.
- Submission: K133298
- Applicant / Sponsor: Meta Biomed, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2014-09-19
Classification & Regulation
This clearance is catalogued under FDA product code EKX and 21 CFR 872.4200, within the Dental review panel as a Class I device.