Cleared Traditional

MODIFICATION TO KAVO QUATTROCARE

K071288 · Sybron Dental Specialties, Inc. · Dental
Jul 2007
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K071288 is an FDA 510(k) clearance for the MODIFICATION TO KAVO QUATTROCARE, 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 July 19, 2007, 72 days after receiving the submission on May 8, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K071288 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2007
Decision Date July 19, 2007
Days to Decision 72 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