Cleared Traditional

K924739 - THE DENTIST'S TOOTH POLISHER

K924739 is an FDA 510(k) clearance for THE DENTIST'S TOOTH POLISHER, manufactured by Ranir/Dcp Corp.. The device is a Class 1 Dental device with product code JEQ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K924739 · Ranir/Dcp Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
63d
Days
Class 1
Risk

K924739 is an FDA 510(k) clearance for the THE DENTIST'S TOOTH POLISHER. Classified as Toothbrush, Powered (product code JEQ), Class I - General Controls.

Submitted by Ranir/Dcp Corp. (Grand Rapids, US). The FDA issued a Cleared decision on November 24, 1992 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6865 - 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 Ranir/Dcp Corp. devices

FDA 510(k) Submission Details - K924739

510(k) Number K924739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1992
Decision Date November 24, 1992
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

JEQ Device Classification - Class 1, General Controls

Product Code JEQ Toothbrush, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6865
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 - JEQ Toothbrush, Powered

All 10
Devices cleared under the same product code (JEQ) and FDA review panel - the closest regulatory comparables to K924739.
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
K935561 · Bausch & Lomb, Inc. · Jan 1994
OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142
K926246 · Omron Healthcare, Inc. · Apr 1993
OMRON TRAVEL TOOTHBRUSH/PLAQUE REMOVER #HT-B005
K926247 · Omron Healthcare, Inc. · Apr 1993
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
K910610 · Bausch & Lomb, Inc. · Jul 1991