510(k) Report

FDA applicant

Nissho Iwai American Corp.

New York, NY1 decision1986–19860 recalls

FDA records 1 decision for Nissho Iwai American Corp. (New York, NY) in 1986: 1 510(k) clearance. All are in product code EBR (Unit, Suction Operatory). 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 Nissho Iwai American Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nissho Iwai American Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nissho Iwai American 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 “Nissho”

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