510(k) Report

FDA applicant

B.T.I. Biotechnology Institute, Sl.

Minano, ES15 decisions2003–20240 recalls

FDA records 15 decisions for B.T.I. Biotechnology Institute, Sl. (Minano, ES) from 2003 to 2024: 15 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 310 days from receipt to decision, against 191 for FDA’s reviews in the same codes and years. Its devices cite 33 predicates, 24 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, dental panel, where it files most

How often FDA has decided B.T.I. Biotechnology Institute, Sl.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 12009: 12010: 12016: 12018: 12021: 12022: 22023: 22024: 1
2007high 2 (2022) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — B.T.I. Biotechnology Institute, Sl. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like B.T.I. Biotechnology Institute, Sl.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form9decisions
  • NHAAbutment, Implant, Dental, Endosseous4decisions
  • LLZSystem, Image Processing, Radiological1decision
  • EJLBur, Dental1decision

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 310 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 191 days; 2 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 33 predicates; 24 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 26 times; 24 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.

  • K022258B.T.I. Biotechnology Institute, S.L. Dental Implant SystemB.T.I. Biotechnology Institute, Sl. · 20037cite it
  • K053355Bti Interna Dental Implant SystemB.T.I. Biotechnology Institute, Sl. · 20067cite it
  • K151391BTI Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 20164cite it
  • K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl. · 20232cite it
  • K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 20222cite it
  • K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 20221cites it

What has FDA decided for it lately?

  • K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl. · 2024
  • K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2023
  • K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl. · 2023
  • K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2022
  • K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2022
  • K202825BTI Extra-Short Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2021
  • K173257BTI Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2018
  • K151391BTI Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2016

All 15 as B.T.I. Biotechnology Institute, Sl. →