Cleared Traditional

TEMPBOND CLEAR WITH TRICLOSAN

K053565 · Sybron Dental Specialties, Inc. · Dental
Feb 2006
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K053565 is an FDA 510(k) clearance for the TEMPBOND CLEAR WITH TRICLOSAN, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Sybron Dental Specialties, Inc. (Newport Beach, US). The FDA issued a Cleared decision on February 3, 2006, 43 days after receiving the submission on December 22, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K053565 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2005
Decision Date February 03, 2006
Days to Decision 43 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