Cleared Traditional

NEXUS 2 CLEAR

K013609 · Sybron Dental Specialties, Inc. · Dental
Jan 2002
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K013609 is an FDA 510(k) clearance for the NEXUS 2 CLEAR, 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 January 16, 2002, 77 days after receiving the submission on October 31, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K013609 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2001
Decision Date January 16, 2002
Days to Decision 77 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