Cleared Traditional

VPro5 (K183018) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183018 · Propel Orthodontics, LLC · Dental device
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Nov 2019
Decision
366d
Days
Class 2
Risk

K183018 is an FDA 510(k) clearance for the VPro5. Classified as Orthodontic Vibratory Accessory (product code OYH), Class II - Special Controls.

Submitted by Propel Orthodontics, LLC (Milpitas, US). The FDA issued a Cleared decision on November 1, 2019 after a review of 366 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.

View all Propel Orthodontics, LLC devices

Submission Details

510(k) Number K183018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2018
Decision Date November 01, 2019
Days to Decision 366 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
239d slower than avg
Panel avg: 127d · This submission: 366d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OYH Orthodontic Vibratory Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition An Orthodontic Accessory Intended For Use During Orthodontic Treatment. It Is Used In Conjunction With Orthodontic Appliances Such As Braces 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.