Cleared Traditional

PRELUDE ONE

K090106 · Danville Materials, Inc. · Dental
Mar 2009
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K090106 is an FDA 510(k) clearance for the PRELUDE ONE, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Danville Materials, Inc. (San Ramon, US). The FDA issued a Cleared decision on March 31, 2009, 89 days after receiving the submission on January 1, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K090106 FDA.gov
FDA Decision Cleared SESE
Date Received January 01, 2009
Decision Date March 31, 2009
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200