Cleared Traditional

CONTINUM

K040179 · Aalba Dent, Inc. · Dental
Mar 2004
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K040179 is an FDA 510(k) clearance for the CONTINUM, 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 March 3, 2004, 36 days after receiving the submission on January 27, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number K040179 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2004
Decision Date March 03, 2004
Days to Decision 36 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