Cleared Traditional

SONICFILL 2010

K091091 · Sybron Dental Specialties, Inc. · Dental
Oct 2009
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K091091 is an FDA 510(k) clearance for the SONICFILL 2010, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on October 14, 2009, 181 days after receiving the submission on April 16, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K091091 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2009
Decision Date October 14, 2009
Days to Decision 181 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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