Cleared Traditional

VERASOFT ES

K033356 · Aalba Dent, Inc. · Dental

Dec 2003

Decision

101d

Days

Class 2

Risk

About This 510(k) Submission

K033356 is an FDA 510(k) clearance for the VERASOFT ES, a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by Aalba Dent, Inc. (Fairfield, US). The FDA issued a Cleared decision on December 30, 2003, 101 days after receiving the submission on September 20, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number	K033356 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2003
Decision Date	December 30, 2003
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement