Cleared Traditional

K143120 - OrthoPulse

K143120 is an FDA 510(k) clearance for OrthoPulse, manufactured by Biolux Research , Ltd.. The device is a Class 2 Dental device with product code PLH cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K143120 · Biolux Research , Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
267d
Days
Class 2
Risk

K143120 is an FDA 510(k) clearance for the OrthoPulse. Classified as Orthodontic Led Accessory (product code PLH), Class II - Special Controls.

Submitted by Biolux Research , Ltd. (Vancouver, CA). The FDA issued a Cleared decision on July 24, 2015 after a review of 267 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.

FDA 510(k) Submission Details - K143120

510(k) Number K143120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2014
Decision Date July 24, 2015
Days to Decision 267 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
139d slower than avg
Panel avg: 128d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

PLH Device Classification - Class 2, Special Controls

Product Code PLH Orthodontic Led Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition Intended For Use During Orthodontic Treatment. It Is Used In Conjunction With Brackets And Wires Or Aligners And Helps Facilitate Minor Anterior Tooth Movement.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Dental devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02267811 Completed Interventional Industry-sponsored

The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement

The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement During Alignment With Fixed Appliances

33
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Malocclusion
Study design Parallel
Eligibility All sexes · 11 Years+
Principal investigator Peter Brawn, DDS
Sponsor Biolux Research Holdings, Inc. (industry)
Started 2013-10-01 → Primary completion 2016-06-01
Primary outcome
Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment
Secondary outcome
Safety Evidence of OrthoPulse™ Use
View full study on ClinicalTrials.gov
K143120 · OrthoPulse
Download PDF FDA Summary Biolux Research , Ltd.