Cleared Traditional

VERABOND 2

K982094 · Aalba Dent, Inc. · Dental
Jul 1998
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K982094 is an FDA 510(k) clearance for the VERABOND 2, 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 July 22, 1998, 37 days after receiving the submission on June 15, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number K982094 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 1998
Decision Date July 22, 1998
Days to Decision 37 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJH — Alloy, Metal, Base
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3710