510(k) Report

FDA applicant

Soadco, S.L.

Escaldes-Engordany, AD11 decisions2002–20240 recalls

FDA records 11 decisions for Soadco, S.L. (Escaldes-Engordany, AD) from 2002 to 2024: 11 510(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 218 days from receipt to decision, against 190 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 9 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 Soadco, S.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2008: 22013: 12016: 22017: 12018: 12023: 12024: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Soadco, S.L. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Soadco, S.L.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form5decisions
  • NHAAbutment, Implant, Dental, Endosseous4decisions
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories2decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 218 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 190 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 24 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 9 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.

  • K122988Klockner Dental Implant AbutmentsSoadco, S.L. · 20133cite it
  • K080224Klockner Essential Dental Implants System, Models Essential Cone (EC), Essential Solid (ES) and EckSoadco, S.L. · 20082cite it
  • K010132Klockner Dental Implants, Models SK, NK, IK, S3, and S4Soadco, S.L. · 20022cite it
  • K151194Klockner Dental Implant Abutments (II)Soadco, S.L. · 20162cite it
  • K052654Klockner Dental Implant, Model S3MSoadco, S.L. · 20061cites it
  • K082200Klockner Essential Dental Implants System, Model Essential Cone 1.5Soadco, S.L. · 20081cites it

What has FDA decided for it lately?

  • K243128Klockner KitsSoadco, S.L. · 2024
  • K230103Klockner AbutmentsSoadco, S.L. · 2023
  • K173642Klockner Surgical BoxSoadco, S.L. · 2018
  • K170022Klockner Vega TiBase for CERECSoadco, S.L. · 2017
  • K153098Klockner Vega Dental Implant SystemSoadco, S.L. · 2016
  • K151194Klockner Dental Implant Abutments (II)Soadco, S.L. · 2016
  • K122988Klockner Dental Implant AbutmentsSoadco, S.L. · 2013
  • K082200Klockner Essential Dental Implants System, Model Essential Cone 1.5Soadco, S.L. · 2008

All 11 as Soadco, S.L. →