510(k) Report

FDA applicant

Propel Orthodontics, LLC

Milpitas, CA3 decisions2015–20190 recalls

FDA records 3 decisions for Propel Orthodontics, LLC (Milpitas, CA) from 2015 to 2019: 3 510(k) clearances. Most are in product codes DZJ (Driver, Wire, And Bone Drill, Manual) and OYH (Orthodontic Vibratory Accessory). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Propel Orthodontics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2015: 12018: 12019: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Propel Orthodontics, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DZJDriver, Wire, And Bone Drill, Manual2decisions
  • OYHOrthodontic Vibratory Accessory1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K150392PROPEL devicePropel Orthodontics, LLC · 20151cites it

What has FDA decided for it lately?

  • K183018VPro5Propel Orthodontics, LLC · 2019
  • K172164PROPEL DevicePropel Orthodontics, LLC · 2018
  • K150392PROPEL devicePropel Orthodontics, LLC · 2015

All 3 as Propel Orthodontics, LLC →