Cleared Traditional

K935542 - NICKEL-TITANIUM K-TYPE FILE

K935542 is an FDA 510(k) clearance for NICKEL-TITANIUM K-TYPE FILE, manufactured by Union Broach, Div. Moyco Industries, Inc.. The device is a Class 1 Dental device with product code EKS cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K935542 · Union Broach, Div. Moyco Industries, Inc. · Dental device
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Jan 1994
Decision
48d
Days
Class 1
Risk

K935542 is an FDA 510(k) clearance for the NICKEL-TITANIUM K-TYPE FILE. Classified as File, Pulp Canal, Endodontic (product code EKS), Class I - General Controls.

Submitted by Union Broach, Div. Moyco Industries, Inc. (Emigsville, US). The FDA issued a Cleared decision on January 3, 1994 after a review of 48 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 Broach, Div. Moyco Industries, Inc. devices

FDA 510(k) Submission Details - K935542

510(k) Number K935542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1993
Decision Date January 03, 1994
Days to Decision 48 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
79d faster than avg
Panel avg: 127d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

EKS Device Classification - Class 1, General Controls

Product Code EKS File, Pulp Canal, 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.

Regulatory Peers - EKS File, Pulp Canal, Endodontic

All 10
Devices cleared under the same product code (EKS) and FDA review panel - the closest regulatory comparables to K935542.
HERO 642
K970649 · Micro-Mega · May 1997
QUANTEC SERIES 2000 ENDODONTIC FILES
K962031 · Tycom Dental · Jun 1996
SHAPING HEDSTROM N.T.
K953604 · Sybron Dental Specialties, Inc. · Sep 1995
DENTAURUM CERAMIC DEBONDING UNIT
K902018 · Dentauraum, Inc. · Apr 1991
VISIONER 21-A
K901037 · J. Morita USA, Inc. · Aug 1990
DENTAL INSTRUMENTS - FILES
K823316 · Miltex, Inc. · Nov 1982