510(k) Report

FDA applicant

Juvora

Thornton-Clevelys, GB3 decisions2014–20180 recalls

FDA records 3 decisions for Juvora (Thornton-Clevelys, GB) from 2014 to 2018: 3 510(k) clearances. All are in product code EBI (Resin, Denture, Relining, Repairing, Rebasing). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Juvora, Ltd.”.

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 Juvora’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2014: 12017: 12018: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Juvora by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EBIResin, Denture, Relining, Repairing, Rebasing3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K160918JUVORA Dental Disc, Ceramill PEEK by JUVORAJuvora · 20172cite it
  • K132725Juvora Dentqal DiscJuvora · 20142cite it

What has FDA decided for it lately?

  • K181331JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster WhiteJuvora, Ltd. · 2018
  • K160918JUVORA Dental Disc, Ceramill PEEK by JUVORAJuvora · 2017
  • K132725Juvora Dentqal DiscJuvora · 2014

All 2 as Juvora →The one decision as Juvora, Ltd. →