Clearance Summary
SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 received FDA 510(k) clearance under submission number K040416, sponsored by Philips Oral 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 2004-07-02.
- Submission: K040416
- Applicant / Sponsor: Philips Oral Healthcare, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6865
- Decision date: 2004-07-02
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.