Clearance Summary
RAPID IMF received FDA 510(k) clearance under submission number K030605, sponsored by Zygomatics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2003-06-27.
- Submission: K030605
- Applicant / Sponsor: Zygomatics , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4600
- Decision date: 2003-06-27
Classification & Regulation
This clearance is catalogued under FDA product code DYX and 21 CFR 872.4600, within the Dental review panel as a Class II device.