Cleared Traditional

K925579 - VERASOFT CASTING ALLOY

K925579 is the FDA 510(k) clearance for VERASOFT CASTING ALLOY by Aalba Dent, Inc.. It is a Class 2 Dental device (product code EJH) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K925579 · Aalba Dent, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
132d
Days
Class 2
Risk

K925579 is an FDA 510(k) clearance for the VERASOFT CASTING ALLOY. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Aalba Dent, Inc. (Chicago, US). The FDA issued a Cleared decision on March 16, 1993 after a review of 132 days - within the typical 510(k) review window.

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 Aalba Dent, Inc. devices

Submission Details

510(k) Number K925579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1992
Decision Date March 16, 1993
Days to Decision 132 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
5d slower than avg
Panel avg: 127d · This submission: 132d
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 K925579.
ARGELITE 81SF+
K934768 · Argen Precious Metals, Inc. · Dec 1993
R1, R2, AND R1+
K922954 · Jeneric/Pentron, Inc. · Jul 1993
DUCERANIUM U
K926347 · Degussa AG · May 1993
DEGUCAST 40
K922790 · Degussa AG · Dec 1992
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