Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Osstem ImplantLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Hiossen with 26 510(k) clearances and 7 device recalls. The most recent is a 510(k) clearance dated May 14, 2026: ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 14, 2026 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsK253372 · NHA | 510(k) clearances |
| Jan 29, 2026 | EK MULTI ANGLED 30 ABUTMENTK251427 · NHA | 510(k) clearances |
| Jan 27, 2025 | ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations suchClass II · Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version wher | Device recalls |
| Jan 27, 2025 | Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport Class II · Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version wher | Device recalls |
| Jan 27, 2025 | ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations suchClass II · Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version wher | Device recalls |
| Jan 27, 2025 | ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations suchClass II · Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version wher | Device recalls |
| Jan 27, 2025 | ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prosthetic restorations such Class II · Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version wher | Device recalls |
| Jan 27, 2025 | Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental implant to provide suport Class II · Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version wher | Device recalls |
| Jan 8, 2025 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)K241003 · NHA | 510(k) clearances |
| Sep 13, 2024 | EK D3.3 and Ultra Wide ImplantsK240232 · DZE | 510(k) clearances |
| May 29, 2024 | EK Digital AbutmentsK233389 · NHA | 510(k) clearances |
| Apr 28, 2023 | ET Abutment SystemK222636 · NHA | 510(k) clearances |
| Apr 6, 2023 | ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010BClass II · Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as | Device recalls |
| Jan 7, 2022 | EK Implants and Abutments SystemK203360 · DZE | 510(k) clearances |
| Dec 16, 2019 | EM ProvisionalK191751 · DZE | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
