Cleared Traditional

K770464 - TOOTHBRUSH, PLAK-A-DENT

K770464 is an FDA 510(k) clearance for TOOTHBRUSH, manufactured by Smith, Ranscht, Pollock, Manos & Connor. The device is a Class 1 Dental device with product code EFW cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K770464 · Smith, Ranscht, Pollock, Manos & Connor · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K770464

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 128d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

EFW Device Classification - Class 1, General Controls

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.

Regulatory Peers - EFW Toothbrush, Manual

All 46
Devices cleared under the same product code (EFW) and FDA review panel - the closest regulatory comparables to K770464.
TOOTHBRUSH, ORTHODONTIC, #0126-0189-00
K771184 · Hoyt Laboratories · Jul 1977
PERIODONTIC TOOTHBRUSH, #0126-0190-00
K771185 · Hoyt Laboratories · Jul 1977
TOOTHBRUSH, REACH
K770749 · Johnson & Johnson Professionals, Inc. · Jun 1977
DENTAL STAIN REMOVER
K761352 · Concept, Inc. · Jan 1977
TOOTHBRUSH
K760512 · Asset Scientific & Pharmaceutical, Inc. · Sep 1976
K770464 · TOOTHBRUSH, PLAK-A-DENT
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