Cleared Traditional

K123416 - INSIGNIA WITH ITERO

K123416 is an FDA 510(k) clearance for INSIGNIA WITH ITERO, manufactured by Ormco Corp.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K123416

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
Combination Product No
PCCP Authorized No
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.

DYW Device Classification - Class 2, Special Controls

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 25
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K123416.
Blue Sky Bio Computerized Orthodontic Bracket System
K182338 · Blue Sky Bio · Nov 2018
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
K180718 · Tomy, Inc. · Oct 2018
INSIGNIA DIGICAST
K123118 · Ormco Corp. · Mar 2013
INSIGNIA
K121524 · Ormco Corp. · Aug 2012
CLEARARCH
K101676 · Ormco Corp. · Sep 2010
OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802
K071055 · Ultradent Products, Inc. · May 2007