Cleared Traditional

FILL-IN

K031476 · Sybron Dental Specialties, Inc. · Dental
Jul 2003
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K031476 is an FDA 510(k) clearance for the FILL-IN, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on July 2, 2003, 54 days after receiving the submission on May 9, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K031476 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2003
Decision Date July 02, 2003
Days to Decision 54 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770

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