Clearance Summary
OPTODENT/OPTOGNATH received FDA 510(k) clearance under submission number K936058, sponsored by Spectrum Healthcare Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-05-16.
- Submission: K936058
- Applicant / Sponsor: Spectrum Healthcare Group
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3590
- Decision date: 1994-05-16
Classification & Regulation
This clearance is catalogued under FDA product code ELM and 21 CFR 872.3590, within the Dental review panel as a Class II device.