Cleared Traditional

VERABOND V

K945712 · Aalba Dent, Inc. · Dental
Dec 1994
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K945712 is an FDA 510(k) clearance for the VERABOND V, 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 29, 1994, 38 days after receiving the submission on November 21, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number K945712 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 1994
Decision Date December 29, 1994
Days to Decision 38 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