FDA applicant

Procera Sandvik, Inc.

Fair Lawn, NJ3 decisions2000–20020 recalls

FDA records 3 decisions for Procera Sandvik, Inc. (Fair Lawn, NJ) from 2000 to 2002: 3 510(k) clearances. All are in product code EIH (Powder, Porcelain). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Procera Sandvik AB”.

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 Procera Sandvik, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Procera Sandvik, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Procera Sandvik, Inc.’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

Procera Sandvik, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?