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HIOSSEN INC.

Last updated September 17, 2026

Information

Country: US
Address: 85 BEN FAIRLESS DR, Fairless Hills, PA, 19030
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3007135442
DUNS Number: —

Catalogue (3217)

Page 1 of 65

Device	Model / Reference	Registries	Class	Status
ET Transfer Abutment	ETTA4555SHW	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4041ONT	FDA UDI	Class II	Active
Smartfit Provisonal Denture	PROHYM	FDA UDI	Class II	Active
Et Smartfit Abutment	P-ETCMASHC	FDA UDI	Class II	Active
ET III Fixture NH Regular [ Implant Only ]	ET3R4011B	FDA UDI	Class II	Active
HG II Fixture Regular RBM Pre-Mounted	AHG2S5011R	FDA UDI	Class II	Active
ET III SA Ultra-Wide Fixture Pre-Mounted	AET3R7006S	FDA UDI	Class II	Active
EK New scan body	EKNSBSTH	FDA UDI	Class I	Active
Em Sa Implant (narrow Ridge)	EMN2511S40	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5077SNW	FDA UDI	Class II	Active
ET Angled Abutment(N) With EG Screw	ETAGA452SNW	FDA UDI	Class II	Active
HM Implant Narrow Ridge	HMN3010R03	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICM4561H	FDA UDI	Class I	Active
EK III NH Fixture No Mount	CEK3S6006B	FDA UDI	Class II	Unknown
ET Angled Abutment Set	ETAA5020NCWH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA7650CP	FDA UDI	Class II	Active
ET Quick Temporary Abutment	ETQTA555RHT	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4565MHW	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR5660HC	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIS5011AC	FDA UDI	Class I	Active
EK III SA Fixture Pre-Mounted	AEK3S3013S	FDA UDI	Class II	Active
ET Rigid Burn-out Cylinder	ETRP700SC	FDA UDI	Class I	Active
EK Healing Abutment	EKHA709	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4065MNW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6650NCWH	FDA UDI	Class II	Active
EK Freeform ST Abutment Straight 5.0(3.0), Hex	EKFAS5030TH	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI4017MN	FDA UDI	Class I	Active
Et Rigid Lab Analog	ETRLA470C	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA4015MHW	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4530HC	FDA UDI	Class I	Active
ET Multi Abutment	ETMA5010CP	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4421	FDA UDI	Class I	Active
Ek Rigid Abutment	EKRA4631P	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S3508S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7024SHW	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI4511SN	FDA UDI	Class I	Active
EK III NH Fixture No Mount	CEK3S4008B	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10CAMHW	FDA UDI	Class II	Active
Ek Angled Abutment_a	EKAA4520ATH	FDA UDI	Class II	Active
Et Pick-Up Guide Pin	ETPGPR150C	FDA UDI	Class I	Active
EK Bite Impression Coping	EKBIC4640H	FDA UDI	Class I	Active
Ek Rigid Abutment	EKRA6730P	FDA UDI	Class II	Active
Ek Bite Index	EKBI4506S	FDA UDI	Class I	Active
ET LinkAbutment (forCerec)Set(Mini)(Non-hex)	ETCTBMNCWH	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S5507B	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S6011B	FDA UDI	Class II	Unknown
Ek Temporary Abutment	EKTTA4010TH	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S3007S	FDA UDI	Class II	Active
Et Freeform St Abutment	ETFSA503SHW	FDA UDI	Class II	Active
ET IV Fixture SA Regular Pre-Mounted	AET4R4508S	FDA UDI	Class II	Active

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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