Cleared Traditional

BEAM BRUSH/BEAM APP

K121165 · Beam Technologies, LLC · Dental

Jun 2012

Decision

65d

Days

Class 1

Risk

About This 510(k) Submission

K121165 is an FDA 510(k) clearance for the BEAM BRUSH/BEAM APP, a Toothbrush, Manual (Class I — General Controls, product code EFW), submitted by Beam Technologies, LLC (Louisville, US). The FDA issued a Cleared decision on June 21, 2012, 65 days after receiving the submission on April 17, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.6855.

Submission Details

510(k) Number	K121165 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 2012
Decision Date	June 21, 2012
Days to Decision	65 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF