510(k) Report

FDA applicant

Elos Medtech Pinol A/S

Goerloese, DK14 decisions2018–20260 recalls

FDA records 14 decisions for Elos Medtech Pinol A/S (Goerloese, DK) from 2018 to 2026: 14 510(k) clearances. All are in product code NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 168 days from receipt to decision, against 156 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 14 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 Elos Medtech Pinol A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018: 12019: 12020: 32021: 12022: 12023: 22024: 22025: 12026 (partial year): 2
2018high 3 (2020) · low 1 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Elos Medtech Pinol A/S by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Elos Medtech Pinol A/S’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?

  • NHAAbutment, Implant, Dental, Endosseous14decisions

How long do its 510(k) reviews take?

Since 2016, its 14 510(k)s took a median of 168 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 156 days; 5 of its 14 were faster than that.

Whose devices does it build on?

Its devices cite 17 predicates; 14 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 14 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.

  • K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S · 20194cite it
  • K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S · 20183cite it
  • K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S · 20202cite it
  • K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S · 20242cite it
  • K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 20232cite it
  • K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S · 20222cite it

What has FDA decided for it lately?

  • K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2026
  • K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S · 2026
  • K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2025
  • K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S · 2024
  • K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S · 2024
  • K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S · 2023
  • K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2023
  • K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S · 2022

All 14 as Elos Medtech Pinol A/S →