Cleared Traditional

K140807 - COMPOSITE ORTHODONTIC BRACKETS

K140807 is an FDA 510(k) clearance for COMPOSITE ORTHODONTIC BRACKETS, manufactured by Ortho Specialties. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K140807

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
Combination Product No
PCCP Authorized No
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.

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 35
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K140807.
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K123118 · Ormco Corp. · Mar 2013
INSIGNIA WITH ITERO
K123416 · Ormco Corp. · Mar 2013
INSIGNIA
K121524 · Ormco Corp. · Aug 2012