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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 59 of 65| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EK III NH Fixture No Mount | CEK3S5008B | FDA UDI | Class II | Active |
| Et Rigid Impression Coping | ETRIC540SC | FDA UDI | Class I | Active |
| HG III Fixture RBM Mini No Mount | CHG3M3513R | FDA UDI | Class II | Active |
| Ek Goldcast Abutment | EKGA4530TH | FDA UDI | Class II | Active |
| ET III Fixture SA Mini Pre-Mounted | AET3M3515S | FDA UDI | Class II | Active |
| ET IV NH Ultra-Wide Fixture Pre-Mounted | AET4R7013B | FDA UDI | Class II | Active |
| Smartfit Final Hybrid Denture -1 | FNLHYD01 | FDA UDI | Class I | Active |
| Et Stud Abutment | ETSAO352M | FDA UDI | Class II | Active |
| ET III Fixture NH Mini D3.2 Pre-Mounted | AET3M3013B | FDA UDI | Class II | Active |
| ET3 D5.5 NH Pre-mounted | AET3R5513B | FDA UDI | Class II | Active |
| ET Multi Abutment | ETMA5020CP | FDA UDI | Class II | Active |
| Esthetic-low Pick-Up Impression Coping Guide Pin | ETGPW150 | FDA UDI | Class I | Active |
| ET Transfer Abutment Set | ETTA4772CWH | FDA UDI | Class II | Active |
| ET III Fixture BA Mini Pre-Mounted | AET3M3510B | FDA UDI | Class II | Active |
| ET IV NH Ultra-Wide Fixture Pre-Mounted | AET4R7008B | FDA UDI | Class II | Active |
| EK III NH Fixture Pre-Mounted | AEK3S4510B | FDA UDI | Class II | Active |
| EK III SA Fixture Pre-Mounted | AEK3S4510S | FDA UDI | Class II | Active |
| ET Transfer Abutment | ETTA6064SNW | FDA UDI | Class II | Active |
| Et Stud Abutment Set | ETSAO352S | FDA UDI | Class II | Active |
| ET Rigid Abutment SET | ETRA6410CP | FDA UDI | Class II | Active |
| ET Transfer Abutment | ETTA5045SHW | FDA UDI | Class II | Active |
| ET Rigid Abutment | ETRGA6054SP | FDA UDI | Class II | Active |
| Em Sa Implant (denture) | EMD2515S40 | FDA UDI | Class II | Active |
| ET Angled Abutment | ETAA4520MNC | FDA UDI | Class II | Active |
| ET Angled Abutment(N) With EG Screw | ETAGA604SNW | FDA UDI | Class II | Active |
| ET Multi Abutment | ETMTA504M | FDA UDI | Class II | Active |
| ET Angled Abutment | ETAA6020BC | FDA UDI | Class II | Active |
| Ek Rigid Abutment | EKRA5450P | FDA UDI | Class II | Active |
| ET Transfer Abutment | ETTA6075SNW | FDA UDI | Class II | Active |
| ET Transfer Abutment | ETTA4527SHW | FDA UDI | Class II | Active |
| ET III SA Ultra-Wide Fixture No Mount | CET3R7010S | FDA UDI | Class II | Active |
| Screw-Multi Angled ABT | ETMABSM | FDA UDI | Class I | Active |
| Bite Impression Coping (Mini) | ETBICM4430 | FDA UDI | Class I | Active |
| ET Transfer Abutment Set | ETTA4722CWH | FDA UDI | Class II | Active |
| ET Transfer Abutment | ETTA5067SHW | FDA UDI | Class II | Active |
| ET Bite Impression Coping | ETBICM4450HC | FDA UDI | Class I | Active |
| ET Multi Abutment | ETMA5050CP | FDA UDI | Class II | Active |
| ET Angled Abutment_B With EG Screw | ETAGA452MBW | FDA UDI | Class II | Active |
| ET II Fixture SA Regular Pre-Mounted | AET2R5013S | FDA UDI | Class II | Active |
| Et Fixture Transfer Impression Coping | ETTIM4514C | FDA UDI | Class I | Active |
| Et Fixture Transfer Impression Coping | ETFTI4011MN | FDA UDI | Class I | Active |
| ET Rigid Abutment SET | ETRAS4711CP | FDA UDI | Class II | Active |
| ET III NH Ultra-Wide Fixture Pre-Mount | AET3R7007B | FDA UDI | Class II | Active |
| ET Rigid Abutment SET | ETRAS4740CP | FDA UDI | Class II | Active |
| ET Transfer Abutment Set | ETTA4751CWH | FDA UDI | Class II | Active |
| ET Bite Impression Coping Hex | ETBICM4420H | FDA UDI | Class I | Active |
| Ek Rigid Abutment | EKRA4621P | FDA UDI | Class II | Active |
| EK Bite Impression Coping | EKBIC4430H | FDA UDI | Class I | Active |
| EK III NH Fixture No Mount | CEK3S4511B | FDA UDI | Class II | Active |
| ET Convertible Polishing Protector | ETCPC600C | 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 |