Cleared Traditional

CONDOR ULTRASONIC INSERTS (K943403) - FDA 510(k) Clearance

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

K943403 · Condor Products, Inc. · Dental device
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Mar 1996
Decision
600d
Days
Class 2
Risk

K943403 is an FDA 510(k) clearance for the CONDOR ULTRASONIC INSERTS. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Condor Products, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on March 5, 1996 after a review of 600 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Condor Products, Inc. devices

Submission Details

510(k) Number K943403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1994
Decision Date March 05, 1996
Days to Decision 600 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
473d slower than avg
Panel avg: 127d · This submission: 600d
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 36
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K943403.
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