510(k) Report

FDA applicant

Hiossen, Inc.

Fariless Hills, PA26 decisions2009–20261 recall

FDA records 26 decisions for Hiossen, Inc. (Fariless Hills, PA) from 2009 to 2026: 26 510(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 240 days from receipt to decision, against 219 for FDA’s reviews in the same codes and years. Its devices cite 49 predicates, 23 of them its own earlier devices. 1 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 Hiossen, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2009: 22010: 22011: 12012: 12013: 32014: 12016: 32017: 12018: 22019: 32022: 12023: 12024: 22025: 12026 (partial year): 2
2009high 3 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2009high 1 (2023) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Hiossen, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hiossen, Inc.’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-Form15decisions
  • NHAAbutment, Implant, Dental, Endosseous9decisions
  • NPMBone Grafting Material, Animal Source1decision
  • EKXHandpiece, Direct Drive, Ac-Powered1decision

How long do its 510(k) reviews take?

Since 2016, its 15 510(k)s took a median of 240 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 219 days; 5 of its 15 were faster than that.

Whose devices does it build on?

Its devices cite 49 predicates; 23 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 37 times; 23 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.

  • K101096HT Iii SA Fixture SystemHiossen, Inc. · 20107cite it
  • K140934Hiossen Implant SystemHiossen, Inc. · 20146cite it
  • K203360EK Implants and Abutments SystemHiossen, Inc. · 20225cite it
  • K123627ET Smartfit AbutmentHiossen, Inc. · 20133cite it
  • K103537ET Iii SA Ultra Wide SystemHiossen, Inc. · 20112cite it
  • K132067Multi Angled Abutment SystemHiossen, Inc. · 20132cite it

What has FDA decided for it lately?

  • K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc. · 2026
  • K251427EK Multi Angled 30 AbutmentHiossen, Inc. · 2026
  • K241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)Hiossen, Inc. · 2025
  • K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc. · 2024
  • K233389EK Digital AbutmentsHiossen, Inc. · 2024
  • K222636ET Abutment SystemHiossen, Inc. · 2023
  • K203360EK Implants and Abutments SystemHiossen, Inc. · 2022
  • K191751EM ProvisionalHiossen, Inc. · 2019

All 26 as Hiossen, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K151626ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for…Apr 6, 2023Class II