Cleared Traditional

K082207 - ORTHOCAD IQ

K082207 is an FDA 510(k) clearance for ORTHOCAD IQ, manufactured by Cadent, Inc.. The device is a Class 2 Dental device with product code DYW cleared through the Traditional 510(k) pathway after a 444-day FDA review.

K082207 · Cadent, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
444d
Days
Class 2
Risk

K082207 is an FDA 510(k) clearance for the ORTHOCAD IQ. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Cadent, Inc. (Washington, US). The FDA issued a Cleared decision on October 23, 2009 after a review of 444 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Cadent, Inc. devices

FDA 510(k) Submission Details - K082207

510(k) Number K082207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2008
Decision Date October 23, 2009
Days to Decision 444 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
317d slower than avg
Panel avg: 127d · This submission: 444d
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 26
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K082207.
INSIGNIA WITH ITERO
K123416 · 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
DAMON 3 MODIFIED
K052477 · Ormco Corp. · Nov 2005
CP BRACKET SYSTEM
K052370 · Dentsply International · Nov 2005