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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: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3007135442
DUNS Number: —

Catalogue (3217)

Page 25 of 65

Device	Model / Reference	Registries	Class	Status
Ek Temporary Abutment	EKTTA4030NTH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA7440NTH	FDA UDI	Class II	Active
]ET III Fixture SA Regular [ Implant Only]	ET3R5011S	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4420CP	FDA UDI	Class II	Active
ET Angled Abutment	ETAA4520BC	FDA UDI	Class II	Active
Esthetic-low Gold Cylinder	ETMGR100TH	FDA UDI	Class I	Active
HS II Fixture Wide RBM Pre-Mounted	AHS2W5008R20	FDA UDI	Class II	Active
ET Convertible Temporary Cylinder	ETCTC400NCWH	FDA UDI	Class I	Active
EK III SA Fixture No Mount	CEK3S6011S	FDA UDI	Class II	Unknown
Et Freeform St Abutment Set	ETFAS5030NCWH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4547SHW	FDA UDI	Class II	Active
Smartfit Try In Hybrid Denture - 3	TRYHYD03	FDA UDI	Class I	Active
Et Rigid Impression Coping	ETRIC4004S	FDA UDI	Class I	Active
ET Bite Impression Coping Hex	ETBICR5420H	FDA UDI	Class I	Active
HS II Fixture Mini RBM Pre-Mounted	AHS2M3510R18	FDA UDI	Class II	Active
ET III Fixture SA Regular Pre-Mounted	AET3R4018S	FDA UDI	Class II	Active
ET Healing Abutment	ETHLA4507R	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6045SHW	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS7011AC	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIS6011AC	FDA UDI	Class I	Active
HG II Fixture RBM Regular No Mount	CHG2S4007R	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S7010B	FDA UDI	Class II	Unknown
EK Freeform ST Abutment 6.0(3.0), Non-hex	EKFA6030NTH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6024SHW	FDA UDI	Class II	Active
HG II Fixture Regular RBM Pre-Mounted	AHG2S4511R	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA6610CP	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4641NCWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4741CWH	FDA UDI	Class II	Active
Ek Fixture Pick-Up Impression Coping	EKPI4016N	FDA UDI	Class I	Active
Ek Rigid Abutment	EKRA4710P	FDA UDI	Class II	Active
EK Pre-milled Abutment	EKPMA14ANNT	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS4511NAC	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTAS4771CWH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4730CP	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4545MHW	FDA UDI	Class II	Active
HS II Fixture Wide RBM Pre-Mounted	AHS2W4507R20	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR5630HC	FDA UDI	Class I	Active
Et Rigid Protect Cap	ETRPC660C	FDA UDI	Class I	Active
ET III Fixture NH Mini D3.2 Pre-Mounted	AET3M3008B	FDA UDI	Class II	Active
Em Sa Implant (denture)	EMD3008S20	FDA UDI	Class II	Active
Et Pick-Up Guide Pin	ETFPG05ML	FDA UDI	Class I	Active
ET3 D5.5 NH Pre-mounted	AET3R5511B	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA5017SP	FDA UDI	Class II	Active
Et Stud Abutment	ETSAO352S	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4641CP	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC5450	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICM4551HC	FDA UDI	Class I	Active
ET Scan body(Intraoral)	ETNSBMSTH	FDA UDI	Class I	Active
ET IV NH Fixture No mount	CET4R5010B	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4065MHW	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