Cleared Traditional

BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH (K974761) - FDA 510(k) Clearance

Class I Dental device.

K974761 · John O. Butler Co. · Dental device
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Jun 1998
Decision
179d
Days
Class 1
Risk

K974761 is an FDA 510(k) clearance for the BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH. Classified as Toothbrush, Manual (product code EFW), Class I - General Controls.

Submitted by John O. Butler Co. (Chicago, US). The FDA issued a Cleared decision on June 16, 1998 after a review of 179 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 John O. Butler Co. devices

Submission Details

510(k) Number K974761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1997
Decision Date June 16, 1998
Days to Decision 179 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 127d · This submission: 179d
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.