SONICARE ADVANCE TOOTHBRUSH, MODEL 4900— 510(k) K040416

Substantially Equivalent

Philips Oral Healthcare, Inc.

FDA 510(k) clearance K040416 for SONICARE ADVANCE TOOTHBRUSH, MODEL 4900, Substantially Equivalent on 2004-07-02. Applicant: Philips Oral Healthcare, Inc..

Clearance details

Applicant
Philips Oral Healthcare, Inc.
Product code
Code JEQ
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Snoqualmie, WA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JEQ

product code JEQ
Injury
188
Malfunction
2,818
Total
3,006

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.