Cleared Traditional

K834580 - REACH* TOOTHBRUSH

K834580 is the FDA 510(k) clearance for REACH* TOOTHBRUSH by Johnson & Johnson Professionals, Inc.. It is a Class 1 Dental device (product code EFW) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K834580 · Johnson & Johnson Professionals, Inc. · Dental device
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Feb 1984
Decision
43d
Days
Class 1
Risk

K834580 is an FDA 510(k) clearance for the REACH* TOOTHBRUSH. Classified as Toothbrush, Manual (product code EFW), Class I - General Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on February 10, 1984 after a review of 43 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K834580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1983
Decision Date February 10, 1984
Days to Decision 43 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
84d faster than avg
Panel avg: 127d · This submission: 43d
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.

Regulatory Peers - EFW Toothbrush, Manual

Devices cleared under the same product code (EFW) and FDA review panel - the closest regulatory comparables to K834580.
LAZERSMILE, LAZERWHITE
K000290 · Biolase Technology, Inc. · Apr 2000
REACH ANTIBACTERIAL TOOTHBRUSH
K971589 · Personal Products Co. · Jul 1997
ORALCHEK SUPER-SOFT BRUSH
K892264 · Pfizer, Inc. · Jun 1989
TOOTHBRUSH, REACH
K770749 · Johnson & Johnson Professionals, Inc. · Jun 1977
DENTAL STAIN REMOVER
K761352 · Concept, Inc. · Jan 1977