Cleared Traditional

K903538 - WIRON 99 DENTAL CASTING ALLOY

K903538 is an FDA 510(k) clearance for WIRON 99 DENTAL CASTING ALLOY, manufactured by Leach and Dillon Co., Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K903538 · Leach and Dillon Co., Inc. · Dental device
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Mar 1991
Decision
220d
Days
Class 2
Risk

K903538 is an FDA 510(k) clearance for the WIRON 99 DENTAL CASTING ALLOY. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Leach and Dillon Co., Inc. (Mansfield, US). The FDA issued a Cleared decision on March 15, 1991 after a review of 220 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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 Leach and Dillon Co., Inc. devices

FDA 510(k) Submission Details - K903538

510(k) Number K903538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1990
Decision Date March 15, 1991
Days to Decision 220 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
93d slower than avg
Panel avg: 127d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJH Device Classification - Class 2, Special Controls

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 99
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K903538.
LPG CASTING ALLOY
K915248 · Aalba Dent, Inc. · Dec 1991
ROCATEC(R) -PLUS
K913857 · Espe GmbH (Us) · Dec 1991
(CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE
K901552 · Nobelpharma USA, Inc. · Jun 1991
VIDENT 90 ALLOY AND VIDENT 95 ALLOY
K903008 · Vident · Sep 1990
TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)
K896501 · Leach and Dillon Co., Inc. · Feb 1990
RX ASPEN
K882170 · Jeneric/Pentron, Inc. · Jun 1988