Cleared Traditional

ORAL-B SUB-BRAND MANUAL TOOTHBRUSH

K073224 · Procter & Gamble · Dental
Feb 2008
Decision
83d
Days
Class 1
Risk

About This 510(k) Submission

K073224 is an FDA 510(k) clearance for the ORAL-B SUB-BRAND MANUAL TOOTHBRUSH, a Toothbrush, Manual (Class I — General Controls, product code EFW), submitted by Procter & Gamble (Mason, US). The FDA issued a Cleared decision on February 6, 2008, 83 days after receiving the submission on November 15, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.6855.

Submission Details

510(k) Number K073224 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2007
Decision Date February 06, 2008
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFW — Toothbrush, Manual
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6855

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