Clearance Summary
SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE received FDA 510(k) clearance under submission number K961494, 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 1996-06-26.
- Submission: K961494
- Applicant / Sponsor: Micro-Mega Societe Anonyme
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1996-06-26
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.