FDA applicant

Britesmile, Inc.

North Attleboro, MA2 decisions2001–20040 recalls

FDA records 2 decisions for Britesmile, Inc. (North Attleboro, MA) from 2001 to 2004: 2 510(k) clearances. All are in product code EIE (Dam, Rubber). Its devices cite 1 predicate, 1 of them its own earlier devices. 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 Britesmile, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Britesmile, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Britesmile, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?