Cleared Traditional

Z BOND, PRELUDE ONE

K111876 · Danville Materials, Inc. · Dental
Sep 2011
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K111876 is an FDA 510(k) clearance for the Z BOND, 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 September 21, 2011, 82 days after receiving the submission on July 1, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K111876 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2011
Decision Date September 21, 2011
Days to Decision 82 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