Cleared Traditional

K973236 - CREST TOOTHBRUSH WITH MICROSHIELD
(FDA 510(k) Clearance)

Mar 1998
Decision
195d
Days
Class 1
Risk

K973236 is an FDA 510(k) clearance for the CREST TOOTHBRUSH WITH MICROSHIELD. This device is classified as a Toothbrush, Manual (Class I - General Controls, product code EFW).

Submitted by Procter & Gamble Co. (Mason, US). The FDA issued a Cleared decision on March 11, 1998, 195 days after receiving the submission on August 28, 1997.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6855.

Submission Details

510(k) Number K973236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1997
Decision Date March 11, 1998
Days to Decision 195 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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