Cleared Traditional

K850666 - STROBEX ULTRON ELECTROSURGE-DENTAL UNIT

K850666 is an FDA 510(k) clearance for STROBEX ULTRON ELECTROSURGE-DENTAL UNIT, manufactured by Ipco Corp.. The device is a Class 2 Dental device with product code EKZ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K850666 · Ipco Corp. · Dental device
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May 1985
Decision
98d
Days
Class 2
Risk

K850666 is an FDA 510(k) clearance for the STROBEX ULTRON ELECTROSURGE-DENTAL UNIT. Classified as Unit, Electrosurgical, And Accessories, Dental (product code EKZ), Class II - Special Controls.

Submitted by Ipco Corp. (White Plains, US). The FDA issued a Cleared decision on May 29, 1985 after a review of 98 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 Ipco Corp. devices

FDA 510(k) Submission Details - K850666

510(k) Number K850666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1985
Decision Date May 29, 1985
Days to Decision 98 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 127d · This submission: 98d
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.