Cleared Traditional

K971589 - REACH ANTIBACTERIAL TOOTHBRUSH

K971589 is an FDA 510(k) clearance for REACH ANTIBACTERIAL TOOTHBRUSH, manufactured by Personal Products Co.. The device is a Class 1 Dental device with product code EFW cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K971589 · Personal Products Co. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
84d
Days
Class 1
Risk

K971589 is an FDA 510(k) clearance for the REACH ANTIBACTERIAL TOOTHBRUSH. Classified as Toothbrush, Manual (product code EFW), Class I - General Controls.

Submitted by Personal Products Co. (Skillman, US). The FDA issued a Cleared decision on July 24, 1997 after a review of 84 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 - K971589

510(k) Number K971589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1997
Decision Date July 24, 1997
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 128d · This submission: 84d
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 48
Devices cleared under the same product code (EFW) and FDA review panel - the closest regulatory comparables to K971589.
PLAQ-ATAQ-I
K980995 · Ethicare · Aug 1998
BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH
K974761 · John O. Butler Co. · Jun 1998
CREST TOOTHBRUSH WITH MICROSHIELD
K973236 · Procter & Gamble Co. · Mar 1998
RANIR HI-TECHNOLOGY DENTAL FLOSS
K955530 · Ranir/Dcp Corp. · Dec 1995
BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH
K950993 · John O. Butler · Jun 1995
ECO TOOTHBRUSH
K930869 · Recycla-Dent, Inc. · May 1993
K971589 · REACH ANTIBACTERIAL TOOTHBRUSH
Download PDF FDA Summary Personal Products Co.