Cleared Traditional

K903538 - WIRON 99 DENTAL CASTING ALLOY

K903538 is the FDA 510(k) clearance for WIRON 99 DENTAL CASTING ALLOY by Leach and Dillon Co., Inc.. It is a Class 2 Dental device (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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Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 36
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K903538.
DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET.
K920561 · Ivoclar North America, Inc. · Mar 1992
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