Cleared Traditional

K020009 - BRACE EZE
(FDA 510(k) Clearance)

K020009 · Udent, Inc. · Dental
Feb 2002
Decision
40d
Days
Class 1
Risk

K020009 is an FDA 510(k) clearance for the BRACE EZE. This device is classified as a Wax, Dental, Intraoral (Class I — General Controls, product code EGD).

Submitted by Udent, Inc. (Pomona, US). The FDA issued a Cleared decision on February 11, 2002, 40 days after receiving the submission on January 2, 2002.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6890.

Submission Details

510(k) Number K020009 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2002
Decision Date February 11, 2002
Days to Decision 40 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EGD — Wax, Dental, Intraoral
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6890