Clearance Summary
ORAL-B SONIC COMPLETE received FDA 510(k) clearance under submission number K061351, sponsored by Braun GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2006-06-05.
- Submission: K061351
- Applicant / Sponsor: Braun GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6865
- Decision date: 2006-06-05
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.