Cleared Traditional

VERABOND 2V

K973265 · Aalba Dent, Inc. · Dental
Oct 1997
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K973265 is an FDA 510(k) clearance for the VERABOND 2V, 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 October 16, 1997, 48 days after receiving the submission on August 29, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number K973265 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1997
Decision Date October 16, 1997
Days to Decision 48 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