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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 52 of 65

Device	Model / Reference	Registries	Class	Status
Em Sa Implant (narrow Ridge)	EMN2508S25	FDA UDI	Class II	Active
Esthetic-low Gold Cylinder	ETMGW200TH	FDA UDI	Class I	Active
ET III NH Ultra-Wide Fixture No-Mount	CET3R7008B	FDA UDI	Class II	Active
A-Oss®	AOSN010LV	FDA UDI	Class II	Unknown
ET Transfer Abutment Set	ETTA6630CWH	FDA UDI	Class II	Active
Et Rigid Protect Cap	ETRPC4504	FDA UDI	Class I	Active
Ek Fixture Pick-Up Impression Coping	EKPI7011N	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA6470CWH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4047MNW	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4544ONT	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA6750TH	FDA UDI	Class II	Active
ET Rigid Burn-out Cylinder	ETRP700BC	FDA UDI	Class I	Active
Et Rigid Retraction Cap	ETRRC461C	FDA UDI	Class I	Active
Ek Fixture Pick-Up Impression Coping	EKPI4016	FDA UDI	Class I	Active
EK III NH Fixture Pre-Mounted	AEK3S3011B	FDA UDI	Class II	Unknown
EK Hybrid Zirconia Abutment	EKHZ4043OHT	FDA UDI	Class II	Active
ET IV NH Ultra-Wide Fixture No mount	CET4R7007B	FDA UDI	Class II	Active
ET III Fixture SA Regular [ Implant Only]	ET3R4015S	FDA UDI	Class II	Active
ET IV Fixture SA Regular No Mount	CET4R4513S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7064SNW	FDA UDI	Class II	Active
ET Scan Body - Cerec	ETCSB	FDA UDI	Class I	Active
ET Multi Ti Base	ETMTB0605G	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5650NCWH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4517SNW	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S6013S	FDA UDI	Class II	Unknown
EK Hybrid Zirconia Abutment	EKHZ4561CHT	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR4641H	FDA UDI	Class I	Active
ET Convertible GoldCast Cylinder	ETGC400CWH	FDA UDI	Class I	Active
ET III Fixture NH Regular [ Implant Only ]	ET3R4507B	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4630HC	FDA UDI	Class I	Active
ET Angled Abutment_A With EG Screw	ETAGA452SAW	FDA UDI	Class II	Active
ET III Fixture NH Mini No-Mounted	CET3M3511B	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4055MP	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS4515NAC	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICM4440HC	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIS6015CA	FDA UDI	Class I	Active
ET Bite Impression Coping Hex	ETBICM4461H	FDA UDI	Class I	Active
ET Angled Abutment(N) With EG Screw	ETAGA552SNW	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI4514SN	FDA UDI	Class I	Active
EK III NH Fixture Pre-Mounted	AEK3S4013B	FDA UDI	Class II	Active
ET III Fixture SA Mini [ Implant Only]	ET3M3508S	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA6037SP	FDA UDI	Class II	Active
ET III NH Ultra-Wide Fixture Pre-Mount	AET3R6013B	FDA UDI	Class II	Active
Smartfit Bone Reduction Guide 2 Holes	ETSGBR02	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA5740CWH	FDA UDI	Class II	Active
ET IV NH Fixture Pre-Mounted	AET4R4513B	FDA UDI	Class II	Active
Smartfit Et Mua Sh Et Mua Regular Hex	ETCMAMASH	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA6064SHW	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4751NTH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5057SHW	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