510(k) Report

FDA applicant

Avinent Implant System S.L.U.

Santpedor, ES3 decisions2020–20260 recalls

FDA records 3 decisions for Avinent Implant System S.L.U. (Santpedor, ES) from 2020 to 2026: 3 510(k) clearances. Most are in product codes KCT (Sterilization Wrap Containers, Trays…) and NXC (Aligner, Sequential). Since 2016 its 510(k)s took a median of 266 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 3 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, general hospital panel, where it files most

How often FDA has decided Avinent Implant System S.L.U.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2020: 12021: 12026 (partial year): 1
2020high 1 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Avinent Implant System S.L.U. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories2decisions
  • NXCAligner, Sequential1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 266 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 134 days; 0 of its 3 were faster than that.

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 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.

  • K191566Avinent Surgical TrayAvinent Implant System S.L.U. · 20202cite it

What has FDA decided for it lately?

  • K260527FACE4D AlignerAvinent Implant System S.L.U. · 2026
  • K201533Avinent Biomimetic Coral and Ocean-Iceberg Sterilization CassettesAvinent Implant System S.L.U. · 2021
  • K191566Avinent Surgical TrayAvinent Implant System S.L.U. · 2020

All 3 as Avinent Implant System S.L.U. →

Other applicant names beginning “Avinent”

FDA records each applicant name separately; these may or may not be the same firm.

Avinent Implant System S.L. 1