Cleared Traditional

STROBEX ULTRON ELECTROSURGE-DENTAL UNIT (K850666) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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.