FDA applicant

Ortho Gnathics, LLC

Pittsburgh, PA1 decision2004–20040 recalls

FDA records 1 decision for Ortho Gnathics, LLC (Pittsburgh, PA) in 2004: 1 510(k) clearance. All are in product code JEY (Plate, Bone). 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 Ortho Gnathics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ortho Gnathics, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ortho Gnathics, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Ortho”

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

Ortho-Clinical Diagnostics, Inc. 152 Ortho Diagnostic Systems, Inc. 126 Ortho Development Corp. 64 Ortho Diagnostics, Inc. 24 Ortho Tec, LLC 22 Ortho Pharmaceutical Corp. 9 Ortho Source 9 Ortho Organizers, Inc. 8 Ortho Kinetics Corp. 7 Ortho Solutions Limited 6 Ortho Instruments 6 Ortho Kinematics, Inc. 6

Ortho Gnathics, LLC

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Ortho”