510(k) Report

FDA applicant

Perflex

Netanya, IL1 decision2015–20150 recalls

FDA records 1 decision for Perflex (Netanya, IL) in 2015: 1 510(k) clearance. All are in product code EBI (Resin, Denture, Relining, Repairing, Rebasing). 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 Perflex’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Perflex by year, 2015–2026Sources: 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, Rebasing1decision

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.

  • K150454Acryfree Denture Base Material and Biosens Denture Base MaterialPerflex · 20151cites it

What has FDA decided for it lately?

  • K150454Acryfree Denture Base Material and Biosens Denture Base MaterialPerflex · 2015

The one decision as Perflex →