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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 61 of 65| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EK Healing Abutment | EKHA505 | FDA UDI | Class II | Active |
| EK III NH Fixture No Mount | CEK3S5510B | FDA UDI | Class II | Active |
| ET Transfer Abutment | ETTA6037SNW | FDA UDI | Class II | Active |
| ET Transfer Abutment | ETTA4545MNW | FDA UDI | Class II | Active |
| Et Freeform St Abutment Set | ETFA4030CWH | FDA UDI | Class II | Active |
| Ek Rigid Abutment | EKRA7640P | FDA UDI | Class II | Active |
| ET Transfer Abutment | ETTA4537MHW | FDA UDI | Class II | Active |
| ET Rigid Abutment | ETRGA4045SP | FDA UDI | Class II | Active |
| EK III SA Fixture No Mount | CEK3S5010S | FDA UDI | Class II | Active |
| ET IV Fixture SA Regular No Mount | CET4R4008S | FDA UDI | Class II | Active |
| ET Transfer Abutment | ETTA5044SHW | FDA UDI | Class II | Active |
| EK New scan body | EKNSBLTH | FDA UDI | Class I | Active |
| ET Abutment Screw, Regular | ETFSRTC | FDA UDI | Class I | Active |
| ET Bite Impression Coping | ETBICM4460HC | FDA UDI | Class I | Active |
| Et Freeform St Abutment Set | ETFA6030CWH | FDA UDI | Class II | Active |
| EK III NH Fixture No Mount | CEK3S3007B | FDA UDI | Class II | Active |
| EK Transfer Abutment | EKTA7620TH | FDA UDI | Class II | Active |
| ET II Fixture SA Regular Pre-Mounted | AET2R4513S | FDA UDI | Class II | Active |
| EK III SA Fixture No Mount | CEK3S7007S | FDA UDI | Class II | Active |
| ET Custom Healing Abutment | ETHLAP9M | FDA UDI | Class II | Active |
| Et Rigid Lab Analog | ETRLA540C | FDA UDI | Class I | Active |
| ET Transfer Abutment | ETTA6035SNW | FDA UDI | Class II | Active |
| ET Rigid Abutment SET | ETRA5620CP | FDA UDI | Class II | Active |
| ET Transfer Abutment Set | ETTA5660NCWH | FDA UDI | Class II | Active |
| ET Transfer Abutment Set | ETTA6720CWH | FDA UDI | Class II | Active |
| ET Rigid Abutment SET | ETRA7610CP | FDA UDI | Class II | Active |
| ET II Fixture SA Regular Pre-Mounted | AET2R4510S | FDA UDI | Class II | Active |
| Et Fixture Transfer Impression Coping | ETTIS6011C | FDA UDI | Class I | Active |
| Et Freeform St Abutment Set | ETFA4015NCWH | FDA UDI | Class II | Active |
| ET Transfer Abutment Set | ETTA5650CWH | FDA UDI | Class II | Active |
| Et Fixture Pick-Up Impression Coping | ETFPI5015SN | FDA UDI | Class I | Active |
| EK III NH Fixture Pre-Mounted | AEK3S3008B | FDA UDI | Class II | Active |
| ET Rigid Abutment SET | ETRAS4750CP | FDA UDI | Class II | Active |
| ET III Fixture SA Mini Pre-Mounted | AET3M3513S | FDA UDI | Class II | Active |
| ET Rigid Abutment SET | ETRAS4610CP | FDA UDI | Class II | Active |
| ET Bite Impression Coping Hex | ETBICM4531H | FDA UDI | Class I | Active |
| ET Angled Abutment Set | ETAA6020BCWH | FDA UDI | Class II | Active |
| Et Rigid Protect Cap | ETRPC461C | FDA UDI | Class I | Active |
| ET III Fixture BA Regular Pre-Mounted | AET3R4513B | FDA UDI | Class II | Active |
| ET Transfer Abutment Set | ETTA4712NCWH | FDA UDI | Class II | Active |
| ET Convertible Abutment | ETCA6020CP | FDA UDI | Class II | Active |
| ET Transfer Abutment | ETTA4035MNW | FDA UDI | Class II | Active |
| ET Angled Abutment | ETAA4540AC | FDA UDI | Class II | Active |
| ET Rigid Abutment SET | ETRA6740CP | FDA UDI | Class II | Active |
| ET Transfer Abutment Set | ETTAS4641NCWH | FDA UDI | Class II | Active |
| ET Angled Abutment Set | ETAA4520MACWH | FDA UDI | Class II | Active |
| ET Transfer Abutment | ETTA6027SNW | FDA UDI | Class II | Active |
| ET Multi Abutment | ETMA5040MCP | FDA UDI | Class II | Active |
| Ek Fixture Lab Analog | EKTLA400 | FDA UDI | Class I | Active |
| EK Bite Impression Coping | EKBIC4450 | FDA UDI | Class I | Active |
Related Companies
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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 |