510(k) Report

FDA applicant

G & H Wire Co.

Greenwood, IN2 decisions1996–20080 recalls

FDA records 2 decisions for G & H Wire Co. (Greenwood, IN) from 1996 to 2008: 2 510(k) clearances. Most are in product codes DZB (Headgear, Extraoral, Orthodontic) and OAT (Implant, Endosseous, Orthodontic). Its devices cite 3 predicates, 0 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 G & H Wire Co.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — G & H Wire Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • DZBHeadgear, Extraoral, Orthodontic1decision
  • OATImplant, Endosseous, Orthodontic1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K081393Orthodontic Temporary Anchorage Implant ScrewG & H Wire Co. · 2008
  • K961754Safety Release ModuleG & H Wire Co. · 1996

All 2 as G & H Wire Co. →