510(k) Report

FDA applicant

H.A. Opotow Consulting

Lake Worth, FL1 decision1992–19920 recalls

FDA records 1 decision for H.A. Opotow Consulting (Lake Worth, FL) in 1992: 1 510(k) clearance. All are in product code EMA (Cement, Dental). 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 H.A. Opotow Consulting’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for H.A. Opotow Consulting since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — H.A. Opotow Consulting by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report