Cleared Traditional

K831749 - ENDODONTIC BROACH(76EKN) BARBED BROACH

K831749 is an FDA 510(k) clearance for ENDODONTIC BROACH(76EKN) BARBED BROACH, manufactured by Union Branch. The device is a Class 1 Dental device with product code EKW cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K831749 · Union Branch · Dental device
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Jul 1983
Decision
50d
Days
Class 1
Risk

K831749 is an FDA 510(k) clearance for the ENDODONTIC BROACH(76EKN) BARBED BROACH. Classified as Broach, Endodontic (product code EKW), Class I - General Controls.

Submitted by Union Branch (Mchenry, US). The FDA issued a Cleared decision on July 12, 1983 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Union Branch devices

FDA 510(k) Submission Details - K831749

510(k) Number K831749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1983
Decision Date July 12, 1983
Days to Decision 50 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 128d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

EKW Device Classification - Class 1, General Controls

Product Code EKW Broach, Endodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.