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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 43 of 65

Device	Model / Reference	Registries	Class	Status
ET Transfer Abutment Set	ETTAS4721NCWH	FDA UDI	Class II	Active
ET III Fixture SA Regular [ Implant Only]	ET3R4515S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5710CWH	FDA UDI	Class II	Active
Et Temporary Abutment	ETTPA401MNT	FDA UDI	Class II	Active
ET Rigid Burn-out Cylinder	ETRBC40S	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTAS4661NCWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5730CWH	FDA UDI	Class II	Active
ET IV Fixture SA Regular No Mount	CET4R4507S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5610CWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4761NCWH	FDA UDI	Class II	Active
Et Rigid Impression Coping	ETRIC470SC	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICR4550HC	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA4567SHW	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4034MP	FDA UDI	Class II	Active
Et Rigid Protect Cap	ETRPC5007S	FDA UDI	Class I	Active
Em Sa Implant (narrow Ridge)	EMN3015S25	FDA UDI	Class II	Active
HG III Fixture RBM Regular Pre-Mounted	AHG3S4508R	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10ARMHW	FDA UDI	Class II	Active
ET IV Fixture SA Regular No Mount	CET4R4508S	FDA UDI	Class II	Active
HG III Fixture RBM Regular Pre-Mounted	AHG3S5010R	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETTIS4011C	FDA UDI	Class I	Active
EK III SA Fixture Pre-Mounted	AEK3S6008S	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5730NTH	FDA UDI	Class II	Active
ET III Fixture BA Regular Pre-Mounted	AET3R5015B	FDA UDI	Class II	Active
Smartfit Final Hybrid Denture - 5	FNLHYD05	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTAS4741NCWH	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S4010B	FDA UDI	Class II	Active
EK Pre-milled Abutment	ETPMA14CARHW	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S5008B	FDA UDI	Class II	Active
ET Healing Abutment	ETHLA4003R	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4543CHT	FDA UDI	Class II	Active
ET Cerec Scan Body	ETCSBC	FDA UDI	Class I	Active
ET IV NH Ultra-Wide Fixture Pre-Mounted	AET4R6010B	FDA UDI	Class II	Active
ET3 D5.5 NH No mount	CET3R5508B	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5044SNW	FDA UDI	Class II	Active
Et Rigid Lab Analog	ETRLA4004	FDA UDI	Class I	Active
ET Convertible Temporary Cylinder Set	ETCTC500TTHC	FDA UDI	Class I	Active
HG II Ultra-Wide Fixture RBM Pre-Mounted	AHG2S6008R	FDA UDI	Class II	Active
ET Convertible Temporary Cylinder	ETCTC500TCTH	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA4632NTH	FDA UDI	Class II	Active
EK Healing Abutment	EKHA453	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6047SNW	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA6014SP	FDA UDI	Class II	Active
Ek Np-Cast Abutment	EKNA4030NTH	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4440HC	FDA UDI	Class I	Active
Em Sa Implant (denture)	EMD2013S20	FDA UDI	Class II	Active
ET III Fixture SA Regular Pre-Mounted	AET3R5018S	FDA UDI	Class II	Active
ET Gold Cast Abutment SET	ETGA4510BCWH	FDA UDI	Class II	Active
HySil Heavy	ESS50H	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5750NTH	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