Cleared Traditional

MAXCEM

K041474 · Sybron Dental Specialties, Inc. · Dental
Jul 2004
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K041474 is an FDA 510(k) clearance for the MAXCEM, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on July 21, 2004, 49 days after receiving the submission on June 2, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K041474 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2004
Decision Date July 21, 2004
Days to Decision 49 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275