510(k) Report

FDA applicant

Orthoaccel Technologies, Inc.

Bellaire, TX3 decisions2011–20160 recalls

FDA records 3 decisions for Orthoaccel Technologies, Inc. (Bellaire, TX) from 2011 to 2016: 3 510(k) clearances. All are in product code OYH (Orthodontic Vibratory Accessory). Its devices cite 4 predicates, 2 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 Orthoaccel Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2011: 12013: 12016: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Orthoaccel Technologies, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Orthoaccel”

FDA records each applicant name separately; these may or may not be the same firm.