Cleared Traditional

K950256 - TURBO 25/30

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

K950256 · Parkell, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Parkell, Inc. devices

Submission Details

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
56d faster than avg
Panel avg: 127d · This submission: 71d
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 K950256.
DENTSPLY CAVITRON SPS SCALER SYSTEM
K970123 · Dentsply Intl. · Apr 1997
CAVITRON JET WITH SPS SYSTEM
K970342 · Dentsply Intl. · Apr 1997
LE CLEAN MACHINE
K950240 · Parkell, Inc. · Apr 1995
JET UNIT (CJ HANDPIECE)
K941392 · Dentsply Intl. · May 1994
INTRA-ORAL IRRIGATOR
K933547 · Parkell, Inc. · Oct 1993
THE MODEL 3003 SCALER
K930698 · Dentsply Intl. · Jul 1993