Clearance Summary
ZX-27 received FDA 510(k) clearance under submission number K133088, sponsored by M&M Dental Studio, 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 2015-01-02.
- Submission: K133088
- Applicant / Sponsor: M&M Dental Studio, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3130
- Decision date: 2015-01-02
Classification & Regulation
This clearance is catalogued under FDA product code EJX and 21 CFR 872.3130, within the Dental review panel as a Class I device.