Cleared Traditional

SONICARE ADVANCE TOOTHBRUSH, MODEL 4900

K040416 · Philips Oral Healthcare, Inc. · Dental

Jul 2004

Decision

135d

Days

Class 1

Risk

About This 510(k) Submission

K040416 is an FDA 510(k) clearance for the SONICARE ADVANCE TOOTHBRUSH, MODEL 4900, a Toothbrush, Powered (Class I — General Controls, product code JEQ), submitted by Philips Oral Healthcare, Inc. (Snoqualmie, US). The FDA issued a Cleared decision on July 2, 2004, 135 days after receiving the submission on February 18, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.6865.

Submission Details

510(k) Number	K040416 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 18, 2004
Decision Date	July 02, 2004
Days to Decision	135 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF