510(k) Report

FDA applicant

Osteo Implant Corp.

New Castle, PA2 decisions1987–19950 recalls

FDA records 2 decisions for Osteo Implant Corp. (New Castle, PA) from 1987 to 1995: 2 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). 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 Osteo Implant Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Osteo Implant Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Osteo”

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