Cleared Traditional

K150702 - Exceed Tx

K150702 is an FDA 510(k) clearance for Exceed Tx, manufactured by Great Lakes Orthodontics, Ltd.. The device is a Class 2 Dental device with product code DYW cleared through the Traditional 510(k) pathway after a 372-day FDA review.

K150702 · Great Lakes Orthodontics, Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
372d
Days
Class 2
Risk

K150702 is an FDA 510(k) clearance for the Exceed Tx. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Great Lakes Orthodontics, Ltd. (Tonawanda, US). The FDA issued a Cleared decision on March 24, 2016 after a review of 372 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K150702

510(k) Number K150702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2015
Decision Date March 24, 2016
Days to Decision 372 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
244d slower than avg
Panel avg: 128d · This submission: 372d
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 K150702.
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
K180718 · Tomy, Inc. · Oct 2018
Carriere Motion Clear Class II
K160720 · Ortho Organizers, Inc. · Nov 2016
CompleClear Plastic Orthodontic Bracket and Wire Appliance
K150830 · Oracrew · Aug 2016
COMPOSITE ORTHODONTIC BRACKETS
K140807 · Ortho Specialties · Nov 2014
INSIGNIA DIGICAST
K123118 · Ormco Corp. · Mar 2013
INSIGNIA WITH ITERO
K123416 · Ormco Corp. · Mar 2013
K150702 · Exceed Tx
Download PDF FDA Summary Great Lakes Orthodont…