FDA applicant

Orthomatics, Inc.

Highlands Ranch, CO1 decision2012–20120 recalls

FDA records 1 decision for Orthomatics, Inc. (Highlands Ranch, CO) in 2012: 1 510(k) clearance. All are in product code EFB (Handpiece, Air-Powered, Dental). 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 Orthomatics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Orthomatics, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Orthomatics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Orthomatics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?