Cleared Traditional

LATIT FLOW

K040465 · Ab Ardent · Dental
Jul 2004
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K040465 is an FDA 510(k) clearance for the LATIT FLOW, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Ab Ardent (Tonawanda, US). The FDA issued a Cleared decision on July 20, 2004, 148 days after receiving the submission on February 23, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K040465 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2004
Decision Date July 20, 2004
Days to Decision 148 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690