510(k) Report

FDA applicant

Ney Dental, Inc.

Deerfield Beach, FL2 decisions1999–19990 recalls

FDA records 2 decisions for Ney Dental, Inc. (Deerfield Beach, FL) in 1999: 2 510(k) clearances. All are in product code EIH (Powder, Porcelain). 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 Ney Dental, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ney Dental, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ney Dental, 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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