510(k) Report

FDA applicant

Tri Dental Innovators

Garden Grove, CA2 decisions2006–20070 recalls

FDA records 2 decisions for Tri Dental Innovators (Garden Grove, CA) from 2006 to 2007: 2 510(k) clearances. All are in product code EBF (Material, Tooth Shade, Resin). Its devices cite 4 predicates, 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 Tri Dental Innovators’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Tri Dental Innovators’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

Which product codes does it file in?

  • EBFMaterial, Tooth Shade, Resin2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K051931AXCELTri Dental Innovators · 20061cites it

What has FDA decided for it lately?

  • K063714Axcel FlowTri Dental Innovators · 2007
  • K051931AXCELTri Dental Innovators · 2006

All 2 as Tri Dental Innovators →