Cleared Traditional

K950239 - SENSIMATIC 500SE

K950239 is an FDA 510(k) clearance for SENSIMATIC 500SE, manufactured by Parkell, Inc.. The device is a Class 2 Dental device with product code EKZ cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K950239 · Parkell, Inc. · Dental device
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Jun 1995
Decision
137d
Days
Class 2
Risk

K950239 is an FDA 510(k) clearance for the SENSIMATIC 500SE. Classified as Unit, Electrosurgical, And Accessories, Dental (product code EKZ), Class II - Special Controls.

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on June 6, 1995 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4920 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Parkell, Inc. devices

FDA 510(k) Submission Details - K950239

510(k) Number K950239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1995
Decision Date June 06, 1995
Days to Decision 137 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
10d slower than avg
Panel avg: 127d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EKZ Device Classification - Class 2, Special Controls

Product Code EKZ Unit, Electrosurgical, And Accessories, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4920
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 - EKZ Unit, Electrosurgical, And Accessories, Dental

All 10
Devices cleared under the same product code (EKZ) and FDA review panel - the closest regulatory comparables to K950239.
ODONTOSURGE 2
K981390 · Periogiene · Jun 1998
ARTHROCARE DENTAL ELECTROSURGERY SYSTEM
K962445 · Arthrocare Corp. · Jul 1996
DENTO-SURGE
K955176 · Ellman Intl., Inc. · Apr 1996
STROBEX ULTRON ELECTROSURGE-DENTAL UNIT
K850666 · Ipco Corp. · May 1985
DIFF 4 SYSTEM
K830441 · Coulter Electronics, Inc. · May 1983