Clearance Summary
SYLVAN DENTAL HEADLIGHT SYSTEM received FDA 510(k) clearance under submission number K923949, sponsored by Sylvan Medical Fiberoptics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1992-10-16.
- Submission: K923949
- Applicant / Sponsor: Sylvan Medical Fiberoptics
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4630
- Decision date: 1992-10-16
Classification & Regulation
This clearance is catalogued under FDA product code EBA and 21 CFR 872.4630, within the Dental review panel as a Class I device.