Cleared Traditional

K950240 - LE CLEAN MACHINE

K950240 is the FDA 510(k) clearance for LE CLEAN MACHINE by Parkell, Inc.. It is a Class 2 Dental device (product code ELC) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K950240 · Parkell, Inc. · Dental device
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Apr 1995
Decision
74d
Days
Class 2
Risk

K950240 is an FDA 510(k) clearance for the LE CLEAN MACHINE. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on April 4, 1995 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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 Parkell, Inc. devices

Submission Details

510(k) Number K950240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1995
Decision Date April 04, 1995
Days to Decision 74 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 127d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELC Scaler, Ultrasonic

All 56
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K950240.
PREMIER ULTRASONIC SCALER AND INSERTS
K010195 · Premier Dental Products Co. · Apr 2001
DENTSPLY CAVITRON SPS SCALER SYSTEM
K970123 · Dentsply Intl. · Apr 1997
CAVITRON JET WITH SPS SYSTEM
K970342 · Dentsply Intl. · Apr 1997
TURBO 25/30
K950256 · Parkell, Inc. · Apr 1995
JET UNIT (CJ HANDPIECE)
K941392 · Dentsply Intl. · May 1994
INTRA-ORAL IRRIGATOR
K933547 · Parkell, Inc. · Oct 1993