Cleared Traditional

WIROBOND C

K032136 · Bego U.S.A. · Dental
Sep 2003
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K032136 is an FDA 510(k) clearance for the WIROBOND C, a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by Bego U.S.A. (Lincoln, US). The FDA issued a Cleared decision on September 4, 2003, 55 days after receiving the submission on July 11, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number K032136 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2003
Decision Date September 04, 2003
Days to Decision 55 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJH — Alloy, Metal, Base
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3710