Cleared Traditional

K123416 - INSIGNIA WITH ITERO

K123416 is the FDA 510(k) clearance for INSIGNIA WITH ITERO by Ormco Corp.. It is a Class 2 Dental device (product code DYW) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K123416 · Ormco Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
127d
Days
Class 2
Risk

K123416 is an FDA 510(k) clearance for the INSIGNIA WITH ITERO. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Ormco Corp. (Orange, US). The FDA issued a Cleared decision on March 13, 2013 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 K123416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2012
Decision Date March 13, 2013
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 DYW Bracket, Plastic, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
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 - DYW Bracket, Plastic, Orthodontic

All 10
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K123416.
Braces on Demand Bracket
K201940 · Braces on Demand, Inc. · Dec 2020
Blue Sky Bio Computerized Orthodontic Bracket System
K182338 · Blue Sky Bio · Nov 2018
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
K180718 · Tomy, Inc. · Oct 2018
OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802
K071055 · Ultradent Products, Inc. · May 2007
MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM
K050730 · Ultradent Products, Inc. · Mar 2005
ORTHODONTIC COMPOSITE BRACKET SYSTEM
K032625 · Ultradent Products, Inc. · Feb 2004