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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 62 of 65

Device	Model / Reference	Registries	Class	Status
HG III Fixture RBM Regular Pre-Mounted	AHG3S4507R	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5750NCWH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4611TH	FDA UDI	Class II	Active
EK cover screw Middle	EKCS40M	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICM4451HC	FDA UDI	Class I	Active
Et Np-Cast Abutment	ETNCA451SNW	FDA UDI	Class II	Active
Et Stud Abutment	ETSAM3530C	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETTIS5011C	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA7630CWH	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI4511MH	FDA UDI	Class I	Active
HG III Fixture RBM Regular Pre-Mounted	AHG3S5013R	FDA UDI	Class II	Active
Et Stud Abutment	ETSAO353S	FDA UDI	Class II	Active
ET3 D5.5 SA Pre-mounted	AET3R5510S	FDA UDI	Class II	Active
ET3 D5.5 NH No mount	CET3R5511B	FDA UDI	Class II	Active
ET III Fixture SA Regular [ Implant Only]	ET3R5010S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4662NCWH	FDA UDI	Class II	Active
Et Goldcast Abutment	ETGCA451SNW	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI7011SN	FDA UDI	Class I	Active
Et Goldcast Abutment	ETGCA401MHW	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4541ONT	FDA UDI	Class II	Active
ET III Fixture NH Mini D3.2 No Mount	CET3M3010B	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4460HC	FDA UDI	Class I	Active
Em Sa Implant (denture)	EMD2513S40	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR5540HC	FDA UDI	Class I	Active
ET IV NH Fixture Pre-Mounted	AET4R4008B	FDA UDI	Class II	Active
EK Healing Abutment	EKHA704	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICM4541H	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA6044SNW	FDA UDI	Class II	Active
ET III Fixture SA Mini No Mount	CET3M3511S	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA6650CP	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIM4015AC	FDA UDI	Class I	Active
EK III SA Fixture Pre-Mounted	AEK3S7008S	FDA UDI	Class II	Unknown
ET Transfer Abutment	ETTA4537SHW	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA7025SP	FDA UDI	Class II	Active
ET O-Ring Retainer Cap Set (Small)	ETRCS02	FDA UDI	Class I	Active
Et Freeform St Abutment Set	ETFAM4015CWH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4651CP	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S5507B	FDA UDI	Class II	Active
ET Convertible Abutment	ETCAS4040CP	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA5610P	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6065SHW	FDA UDI	Class II	Active
Et Stud Abutment	ETSAO355M	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S5010B	FDA UDI	Class II	Active
Ek Fixture Pick-Up Impression Coping	EKPI6011	FDA UDI	Class I	Active
ET Convertible Combination Cylinder	ETCC4070CWH	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA4044MP	FDA UDI	Class II	Active
ET Convertible Abutment	ETCAS4020CP	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETTIS6014C	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA7420NCWH	FDA UDI	Class II	Active
Smartfit Et Mua Sn Et Mua Regular Hex	ETCMAMASN	FDA UDI	Class I	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