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Sign in to claim this brandHIOSSEN INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 85 BEN FAIRLESS DR, Fairless Hills, PA, 19030
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3007135442
- DUNS Number
- —
Catalogue (3217)
Page 65 of 65| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ETIII SA Fixture System (O3.2mm) | K153332 | FDA 510(k) | Class II | Active |
| ET IV SA Dental Implants | K183242 | FDA 510(k) | Class II | Active |
| A-Oss | K151542 | FDA 510(k) | Class II | Active |
| Hg Ii Fixture System | K090237 | FDA 510(k) | Class II | Active |
| EK Digital Abutments | K233389 | FDA 510(k) | Class II | Active |
| Is3 | K180527 | FDA 510(k) | Class I | Active |
| Hiossen Implant System | K140934 | FDA 510(k) | Class II | Active |
| Ht Iii Sa Fixture System | K101096 | FDA 510(k) | Class II | Active |
| Et Smartfit Abutment | K123627 | FDA 510(k) | Class II | Active |
| ET III Bio-SA Fixture System | K151626 | FDA 510(k) | Class II | Active |
| EM SA Implant System | K191201 | FDA 510(k) | Class II | Active |
| Modification To: Hg Iii Ultra Wide System | K093889 | FDA 510(k) | Class II | Active |
| HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) | K241003 | FDA 510(k) | Class II | Active |
| EK Implants and Abutments System | K203360 | FDA 510(k) | Class II | Active |
| Etii Sa Fixture System | K123471 | FDA 510(k) | Class II | Active |
| Et Iii Sa Ultra Wide System | K103537 | FDA 510(k) | Class II | Active |
| ET Hybrid Abutment | K162390 | FDA 510(k) | Class II | Active |
Related Companies
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Authorities
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FDA Recalls (6)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 27, 2025 | Z-1271-2025 | — | open, classified | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version |
| Jan 27, 2025 | Z-1275-2025 | — | open, classified | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version |
| Jan 27, 2025 | Z-1273-2025 | — | open, classified | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version |
| Jan 27, 2025 | Z-1274-2025 | — | open, classified | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version |
| Jan 27, 2025 | Z-1276-2025 | — | open, classified | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version |
| Jan 27, 2025 | Z-1272-2025 | — | open, classified | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version |