Cleared Traditional

TOOTHBRUSH, PLAK-A-DENT (K770464) - FDA 510(k) Clearance

Class I Dental device.

K770464 · Smith, Ranscht, Pollock, Manos & Connor · Dental device
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Apr 1977
Decision
35d
Days
Class 1
Risk

K770464 is an FDA 510(k) clearance for the TOOTHBRUSH, PLAK-A-DENT. Classified as Toothbrush, Manual (product code EFW), Class I - General Controls.

Submitted by Smith, Ranscht, Pollock, Manos & Connor (Mchenry, US). The FDA issued a Cleared decision on April 8, 1977 after a review of 35 days - a notably fast clearance 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: 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 Smith, Ranscht, Pollock, Manos & Connor devices

Submission Details

510(k) Number K770464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1977
Decision Date April 08, 1977
Days to Decision 35 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 127d · This submission: 35d
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.