Cleared Traditional

K955176 - DENTO-SURGE

K955176 is an FDA 510(k) clearance for DENTO-SURGE, manufactured by Ellman Intl., Inc.. The device is a Class 2 Dental device with product code EKZ cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K955176 · Ellman Intl., Inc. · Dental device
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Apr 1996
Decision
154d
Days
Class 2
Risk

K955176 is an FDA 510(k) clearance for the DENTO-SURGE. Classified as Unit, Electrosurgical, And Accessories, Dental (product code EKZ), Class II - Special Controls.

Submitted by Ellman Intl., Inc. (Sound Beach, US). The FDA issued a Cleared decision on April 15, 1996 after a review of 154 days - an extended review cycle.

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 Ellman Intl., Inc. devices

FDA 510(k) Submission Details - K955176

510(k) Number K955176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date April 15, 1996
Days to Decision 154 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
27d slower than avg
Panel avg: 127d · This submission: 154d
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 8
Devices cleared under the same product code (EKZ) and FDA review panel - the closest regulatory comparables to K955176.
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
K000768 · Wallach Surgical Devices, Inc. · Apr 2000
BI-DENT
K982229 · Valley Forge Scientific Corp. · Aug 1998
ARTHROCARE DENTAL ELECTROSURGERY SYSTEM
K962445 · Arthrocare Corp. · Jul 1996
SENSIMATIC 500SE
K950239 · Parkell, Inc. · Jun 1995
STROBEX ULTRON ELECTROSURGE-DENTAL UNIT
K850666 · Ipco Corp. · May 1985
DIFF 4 SYSTEM
K830441 · Coulter Electronics, Inc. · May 1983