FDA applicant

Operart, LLC

Santa Monica, CA1 decision2017–20170 recalls

FDA records 1 decision for Operart, LLC (Santa Monica, CA) in 2017: 1 510(k) clearance. 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 Operart, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Operart, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Operart, LLC

Which product codes does it file in?

What has FDA decided for it lately?