Cleared Traditional

SONICWAVE SONIC PLAQUE REMOVER

K012914 · Homedics, Inc. · Dental

Oct 2001

Decision

32d

Days

Class 1

Risk

About This 510(k) Submission

K012914 is an FDA 510(k) clearance for the SONICWAVE SONIC PLAQUE REMOVER, a Toothbrush, Powered (Class I — General Controls, product code JEQ), submitted by Homedics, Inc. (Commerce Township, US). The FDA issued a Cleared decision on October 1, 2001, 32 days after receiving the submission on August 30, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.6865.

Submission Details

510(k) Number	K012914 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 2001
Decision Date	October 01, 2001
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF