Cleared Traditional

K950256 - TURBO 25/30

K950256 is an FDA 510(k) clearance for TURBO 25/30, manufactured by Parkell, Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K950256 · Parkell, Inc. · Dental device
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Apr 1995
Decision
71d
Days
Class 2
Risk

K950256 is an FDA 510(k) clearance for the TURBO 25/30. 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 71 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.

FDA 510(k) Submission Details - K950256

510(k) Number K950256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1995
Decision Date April 04, 1995
Days to Decision 71 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
57d faster than avg
Panel avg: 128d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

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 194
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K950256.
MICRO ICS SONIC SCALER
K942380 · Micro Motors, Inc. · Aug 1995
RELACS 7000
K951272 · Micro-Mega Societe Anonyme · May 1995
LE CLEAN MACHINE
K950240 · Parkell, Inc. · Apr 1995
JET UNIT (CJ HANDPIECE)
K941392 · Dentsply Intl. · May 1994
ENDODONTIC PULP CANAL SPREADER
K934714 · Excellence IN Endodontics, Inc. · Feb 1994
AMDENT 2030, POLISHER/SCALER
K920328 · Amdent AB · Oct 1993
K950256 · TURBO 25/30
Download PDF Parkell, Inc.