Clearance Summary
IMKB CONTRA-ANGLES received FDA 510(k) clearance under submission number K933639, sponsored by Micro-Mega. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-09-21.
- Submission: K933639
- Applicant / Sponsor: Micro-Mega
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1994-09-21
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.