Clearance Summary
ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH received FDA 510(k) clearance under submission number K936076, sponsored by Ohio Health Care Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-01-26.
- Submission: K936076
- Applicant / Sponsor: Ohio Health Care Products, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6865
- Decision date: 1994-01-26
Classification & Regulation
This clearance is catalogued under FDA product code JEQ and 21 CFR 872.6865, within the Dental review panel as a Class I device.