510(k) Report

FDA applicant

Rhondium, Ltd.

Katikati, NZ2 decisions2015–20161 recall

FDA records 2 decisions for Rhondium, Ltd. (Katikati, NZ) from 2015 to 2016: 2 510(k) clearances. Most are in product codes EIH (Powder, Porcelain) and EBF (Material, Tooth Shade, Resin). Its devices cite 8 predicates, 1 of them its own earlier devices. 1 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 Rhondium, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2015: 12016: 1
2015high 1 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2015high 1 (2019) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Rhondium, Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Rhondium, Ltd.’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?

  • EIHPowder, Porcelain1decision
  • EBFMaterial, Tooth Shade, Resin1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K143694Rhondium One-Visit-Crown (OVC)Rhondium, Ltd. · 20152cite it

What has FDA decided for it lately?

  • K162677L- OVCRhondium, Ltd. · 2016
  • K143694Rhondium One-Visit-Crown (OVC)Rhondium, Ltd. · 20151 recall

All 2 as Rhondium, Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K143694Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The…Jan 31, 2019Class II