510(k) Report

FDA applicant

Hines Group, Ltd.

Nyw York, NY1 decision1995–19950 recalls

FDA records 1 decision for Hines Group, Ltd. (Nyw York, NY) in 1995: 1 510(k) clearance. All are in product code EAX (Mirror, Mouth). 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 Hines Group, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hines Group, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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