Clearance Summary
SERIES XE, SERIES SE, SERIES TE received FDA 510(k) clearance under submission number K971350, sponsored by Micro-Mega Societe Anonyme. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1997-06-04.
- Submission: K971350
- Applicant / Sponsor: Micro-Mega Societe Anonyme
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1997-06-04
Classification & Regulation
This clearance is catalogued under FDA product code EGS and 21 CFR 872.4200, within the Dental review panel as a Class I device.