Cleared Traditional

K140807 - COMPOSITE ORTHODONTIC BRACKETS

K140807 is the FDA 510(k) clearance for COMPOSITE ORTHODONTIC BRACKETS by Ortho Specialties. It is a Class 2 Dental device (product code DYW) cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K140807 · Ortho Specialties · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
225d
Days
Class 2
Risk

K140807 is an FDA 510(k) clearance for the COMPOSITE ORTHODONTIC BRACKETS. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Ortho Specialties (Gurnee, US). The FDA issued a Cleared decision on November 12, 2014 after a review of 225 days - an extended review 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: 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 Ortho Specialties devices

Submission Details

510(k) Number K140807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2014
Decision Date November 12, 2014
Days to Decision 225 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
98d slower than avg
Panel avg: 127d · This submission: 225d
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 K140807.
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