Cleared Traditional

ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES (K061199) - FDA 510(k) Clearance

Class I Dental device.

K061199 · Braun GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
33d
Days
Class 1
Risk

K061199 is an FDA 510(k) clearance for the ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES. Classified as Toothbrush, Powered (product code JEQ), Class I - General Controls.

Submitted by Braun GmbH (Boston, US). The FDA issued a Cleared decision on May 31, 2006 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6865 - 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 Braun GmbH devices

Submission Details

510(k) Number K061199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2006
Decision Date May 31, 2006
Days to Decision 33 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
94d faster than avg
Panel avg: 127d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JEQ Toothbrush, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6865
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.