Cleared Traditional

BEAM BRUSH/BEAM APP (K121165) - FDA 510(k) Clearance

Class I Dental device.

K121165 · Beam Technologies, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
65d
Days
Class 1
Risk

K121165 is an FDA 510(k) clearance for the BEAM BRUSH/BEAM APP. Classified as Toothbrush, Manual (product code EFW), Class I - General Controls.

Submitted by Beam Technologies, LLC (Louisville, US). The FDA issued a Cleared decision on June 21, 2012 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6855 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Beam Technologies, LLC devices

Submission Details

510(k) Number K121165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 127d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFW Toothbrush, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6855
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.