FDA applicant

Opti-Max

Port Ludlow, WA6 decisions1995–19970 recalls

FDA records 6 decisions for Opti-Max (Port Ludlow, WA) from 1995 to 1997: 6 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). 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 Opti-Max’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Opti-Max since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Opti-Max”

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

Opti-Centre Laboratories 6 Opti Medical Systems, Inc. 3 Opti-Ray, Inc. 2 Opti-Med Electronics 1

Opti-Max

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Opti-Max”