510(k) Report

FDA applicant

Buffalo Dental Mfg. Co., Inc.

Mchenry, IL11 decisions1980–19960 recalls

FDA records 11 decisions for Buffalo Dental Mfg. Co., Inc. (Mchenry, IL) from 1980 to 1996: 11 510(k) clearances. Most are in product codes ELW (Material, Impression) and EHY (Tray, Impression, Preformed). 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 Buffalo Dental Mfg. Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Buffalo Dental Mfg. Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Buffalo Dental Mfg. Co., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Buffalo Dental Mfg. Co., Inc.’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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Other applicant names beginning “Buffalo”

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