510(k) Report

FDA applicant

Bioloren S.R.L.

Saronno, IT3 decisions2011–20180 recalls

FDA records 3 decisions for Bioloren S.R.L. (Saronno, IT) from 2011 to 2018: 3 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EBG (Crown And Bridge, Temporary, Resin). 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 Bioloren S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2011: 12013: 12018: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Bioloren S.R.L. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EBFMaterial, Tooth Shade, Resin2decisions
  • EBGCrown And Bridge, Temporary, Resin1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K121735Fiber Disk and Block Permanent, TriniaBioloren S.R.L. · 20131cites it

What has FDA decided for it lately?

  • K173643Trilor Disks, Blocks and ArchesBioloren S.R.L. · 2018
  • K121735Fiber Disk and Block Permanent, TriniaBioloren S.R.L. · 2013
  • K112186Fiber Disk and BlockBioloren S.R.L. · 2011

All 3 as Bioloren S.R.L. →