Hiossen ET III SA
Also known as: ET III SA, ETIII SA, ET III
A tapered two-piece implant from Hiossen, the US arm of Osstem Implant, finished with a sandblasted and acid-etched SA surface and supplied on two connection sizes.
Quick facts
| Manufacturer | Hiossen, Inc. — Hiossen states it was established by its parent company Osstem in 2006 in Pennsylvania and became Hiossen Implant in 2007Manufacturer-reported[1]Hiossen describes Osstem as its parent company on its own corporate page; the two are related companies, not independent competitors. |
|---|---|
| Implant level | Bone levelVerified spec[2]In its own 510(k) K153332, Hiossen sets out a substantial-equivalence matrix whose primary predicate is the HIOSSEN Implant System (K140934) — the clearance that covers the tapered ETIII SA fixture in body diameters 3.5 to 6.8 mm — and lists that device's structure as 'Internal Hex / Bone Level Implant / Tapered body shape / 3 sided cutting edge with self-tapping'. Confidence is held at medium because the wording appears in the predicate column of a comparison table rather than in a description of the ET III SA fixture itself; K140934 characterises the same fixture only as a 'Submerged Fixture', and the Hiossen ET III SA catalogue does not use bone-level or tissue-level vocabulary. |
| Body geometry | Tapered body; Hiossen states a 1.5-degree taper for ET IIIManufacturer-reported[3] |
| Thread design | Combination described by Hiossen as an open thread to avoid bone necrosis, a single-pitch thread matched to the SA surface, a corkscrew thread for self-threading and a helix cutting edge for path controlManufacturer-reported[4] |
| Apex design | Apical design stated to have self-drilling ability and to increase initial stability in fresh extraction socketsManufacturer-reported[4] |
| Material | Commercially pure titanium, grade 4, to ASTM F67Verified spec[5]Hiossen's 510(k) K140934 gives the material of the ETIII SA Fixture as 'Pure Titanium (ASTM F 67)' in the device description and as 'Pure Titanium Grade 4 (ASTM F67)' in the substantial-equivalence matrix. This applies to the ET III SA range recorded here. The separate Ø3.2 mm ETIII SA fixture cleared later under K153332 is a different substrate — titanium alloy Ti-6Al-4V to ASTM F136 — and is not part of the Ø3.5 to 5.0 range on this page. |
| Surface | SA — sandblasted with alumina and acid-etched, described as a combination of crater and micro-pit morphologyManufacturer-reported[4] |
| Connection | Two connection sizes: a Mini connection on the Ø3.5 fixture and a Standard connection shared by Ø4.0, Ø4.5 and Ø5.0, with a single abutment range across the standard sizesManufacturer-reported[4]The catalogue does not state a taper angle for the connection. |
| Platform switching | Manufacturer documentation not located |
| Available diameters | Ø3.5, 4.0, 4.5 and 5.0 mmManufacturer-reported[4] |
| Available lengths | Ø3.5 in 8.5, 10, 11.5, 13 and 15 mm; Ø4.0, Ø4.5 and Ø5.0 in 7, 8.5, 10, 11.5, 13 and 15 mmManufacturer-reported[4] |
Overview
Clinical positioning
What the manufacturer says this system is designed for. This is not the same thing as independent clinical evidence, which is set out separately below.
Further detail
| Geographic availability | Requires manual verification |
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Clinical evidence
We have not yet completed a system-specific evidence review for Hiossen ET III SA. Insufficient system-specific evidence How we grade evidence
Similar implant systems
Popular comparisons
The clearances below are held by Hiossen at brand level and cover its implant range, not Hiossen ET III SA specifically. We show them here because that is the level at which regulators actually issue them.
Regulatory record
Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →
FDA 510(k) clearance3 records
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
Other2 records
Registered device establishment in United States. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.
| Number | Device | Holder | Date |
|---|---|---|---|
| 3007135442 | — | HIOSSEN INC. | — |
| 1257 device records | — | Hiossen | — |
Clearance records for Hiossen were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Hiossen.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]About Us — Hiossen Implant — Hiossen, Inc.. Accessed 2026-07-21.
- [2]FDA 510(k) K153332 — ETIII SA Fixture System (Ø3.2 mm) — U.S. Food & Drug Administration, 2016. Accessed 2026-07-22.
- [3]ET Implant System — Hiossen, Inc.. Accessed 2026-07-21.
- [4]ET III SA Implant System & Prosthetic Components — Catalog & Manual — Hiossen Implant Europe. Accessed 2026-07-21.
- [5]FDA 510(k) K140934 — HIOSSEN Implant System (ETIII SA Fixture) — U.S. Food & Drug Administration, 2014. Accessed 2026-07-22.