Cleared Traditional

VERASOFT CASTING ALLOY

K925579 · Aalba Dent, Inc. · Dental

Mar 1993

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K925579 is an FDA 510(k) clearance for the VERASOFT CASTING ALLOY, a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by Aalba Dent, Inc. (Chicago, US). The FDA issued a Cleared decision on March 16, 1993, 132 days after receiving the submission on November 4, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number	K925579 FDA.gov
FDA Decision	Cleared 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