Cleared Traditional

SILJETR SYSTEM

K110642 · Danville Materials, Inc. · Dental
May 2011
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K110642 is an FDA 510(k) clearance for the SILJETR SYSTEM, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Danville Materials, Inc. (San Ramon, US). The FDA issued a Cleared decision on May 27, 2011, 81 days after receiving the submission on March 7, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K110642 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2011
Decision Date May 27, 2011
Days to Decision 81 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