510(k) Report

FDA applicant

Dental Arte, Inc.

Braderdon, FL2 decisions2006–20110 recalls

FDA records 2 decisions for Dental Arte, Inc. (Braderdon, FL) from 2006 to 2011: 2 510(k) clearances. Most are in product codes OBR (Mouthguard, Over-The-Counter) and EIH (Powder, Porcelain). Its devices cite 1 predicate, 0 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 Dental Arte, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • OBRMouthguard, Over-The-Counter1decision
  • EIHPowder, Porcelain1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K111310Brux MouthguardsDental Arte, Inc. · 2011
  • K060086Feniiiiiix Coloration KitDental Arte, Inc. · 2006

All 2 as Dental Arte, Inc. →