Cleared Traditional

K081415 - DAMON 4CLEAR

K081415 is the FDA 510(k) clearance for DAMON 4CLEAR by Ormco Corp.. It is a Class 2 Dental device (product code NJM) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K081415 · Ormco Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
127d
Days
Class 2
Risk

K081415 is an FDA 510(k) clearance for the DAMON 4CLEAR. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Ormco Corp. (Orange, US). The FDA issued a Cleared decision on September 24, 2008 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ormco Corp. devices

Submission Details

510(k) Number K081415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2008
Decision Date September 24, 2008
Days to Decision 127 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 127d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NJM Bracket, Ceramic, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition An Orthodontic Ceramic Bracket Is A Device Composed Of Ceramic, Which Is Intended To Be Bonded To A Tooth, Upon Which An Orthodontic Wire Is Used To Move The Tooth To A New Position.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NJM Bracket, Ceramic, Orthodontic

All 22
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K081415.
3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
K180404 · 3M Healthcare · Mar 2018
Carriere SLX 3D Clear
K173440 · Ortho Organizers, Inc. · Mar 2018
Symetri Clear
K172845 · Ormco Corporation · Jan 2018
NEO-CLIP ORTHODONTIC BRACKET ACCESSORY
K042905 · Dentsply Intl. · Nov 2004
ORTHODONTIC CERAMIC BRACKETS
K042178 · Dentsply Intl. · Aug 2004