Cleared Traditional

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

Class I Dental device.

K973236 · Procter & Gamble Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
195d
Days
Class 1
Risk

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

Submitted by Procter & Gamble Co. (Mason, US). The FDA issued a Cleared decision on March 11, 1998 after a review of 195 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Procter & Gamble Co. devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 127d · This submission: 195d
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.