Cleared Traditional

K121524 - INSIGNIA

K121524 is an FDA 510(k) clearance for INSIGNIA, 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 78-day FDA review.

K121524 · Ormco Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
78d
Days
Class 2
Risk

K121524 is an FDA 510(k) clearance for the INSIGNIA. 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 August 9, 2012 after a review of 78 days - a notably fast clearance cycle.

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: 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 - K121524

510(k) Number K121524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2012
Decision Date August 09, 2012
Days to Decision 78 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
50d faster than avg
Panel avg: 128d · This submission: 78d
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 39
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K121524.
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K121524 · INSIGNIA
Download PDF FDA Summary Ormco Corp.