Cleared Traditional

K020009 - BRACE EZE

K020009 is an FDA 510(k) clearance for BRACE EZE, manufactured by Udent, Inc.. The device is a Class 1 Dental device with product code EGD cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K020009 · Udent, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
40d
Days
Class 1
Risk

K020009 is an FDA 510(k) clearance for the BRACE EZE. Classified as Wax, Dental, Intraoral (product code EGD), Class I - General Controls.

Submitted by Udent, Inc. (Pomona, US). The FDA issued a Cleared decision on February 11, 2002 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6890 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K020009

510(k) Number K020009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 128d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

EGD Device Classification - Class 1, General Controls

Product Code EGD Wax, Dental, Intraoral
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6890
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EGD Wax, Dental, Intraoral

All 24
Devices cleared under the same product code (EGD) and FDA review panel - the closest regulatory comparables to K020009.
GLENROE ORTHO-SIL
K945535 · Glenroe Technologies · Jan 1995
ORTHO WAX
K924024 · Heraeus Kulzer, Inc. · Nov 1992
BURNOUT MATERIAL
K923586 · Dentsply Intl. · Sep 1992
SALIVA-STIM
K914892 · Orion Diagnostica, Inc. · Sep 1992
BITE RIM WAX
K922380 · Dentsply Intl. · Jun 1992
PALAVIT G
K914513 · Heraeus Kulzer, Inc. · Mar 1992
K020009 · BRACE EZE
Download PDF FDA Summary Udent, Inc.