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)
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.

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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
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 127d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.