Clearance Summary
OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142 received FDA 510(k) clearance under submission number K926246, sponsored by Omron Healthcare, 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 1993-04-14.
- Submission: K926246
- Applicant / Sponsor: Omron Healthcare, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6865
- Decision date: 1993-04-14
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.