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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 13 of 65

Device	Model / Reference	Registries	Class	Status
Et Rigid Impression Coping	ETRIC6004S	FDA UDI	Class I	Active
Et Fixture Transfer Impression Coping	ETFTI5011SH	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA6034SP	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7035SNW	FDA UDI	Class II	Active
ET Temporary Abutment SET	ETTTA4510CTH	FDA UDI	Class II	Active
ET3 D5.5 SA Pre-mounted	AET3R5508S	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4044SP	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA7650NCWH	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S6010S	FDA UDI	Class II	Active
ET IV Fixture SA Regular No Mount	CET4R5013S	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4535MP	FDA UDI	Class II	Active
ET II Fixture SA Regular No-Mounted	CET2R4010S	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5740NTH	FDA UDI	Class II	Active
ET IV Fixture SA Ultra-Wide Pre-Mounted	AET4R6013S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4731NCWH	FDA UDI	Class II	Active
Et Bite Index	ETBIS5508S	FDA UDI	Class I	Active
ET Rigid Abutment SET	ETRA7620CP	FDA UDI	Class II	Active
ET SmartFit Abutment	ETCMAMN	FDA UDI	Class II	Active
HM Implant Narrow Ridge	HMN2513R03	FDA UDI	Class II	Active
HG II Fixture Mini RBM Pre-Mounted	AHG2M3513R	FDA UDI	Class II	Active
HG III Ultra-Wide Fixture RBM Pre-Mounted	AHG3S6011R	FDA UDI	Class II	Active
ET II Fixture SA Regular Pre-Mounted	AET2R5010S	FDA UDI	Class II	Active
ET IV NH Ultra-Wide Fixture Pre-Mounted	AET4R7011B	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S7011B	FDA UDI	Class II	Active
Ek Fixture Pick-Up Impression Coping	EKPI4511N	FDA UDI	Class I	Active
Et Ziocera Abutment	ETZCA553SNW	FDA UDI	Class II	Active
Ek Stud Abutment Small	EKST3530	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4440	FDA UDI	Class I	Active
EK III NH Fixture No Mount	CEK3S7011B	FDA UDI	Class II	Unknown
Et Freeform St Abutment	ETFSA501SNW	FDA UDI	Class II	Active
ET O-ring Lab Analog (Small)	ETOAL02	FDA UDI	Class I	Active
ET Convertible Plastic Cylinder	ETCPL600CWH	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIS5011CA	FDA UDI	Class I	Active
Et Fixture Transfer Impression Coping	ETTIS5014C	FDA UDI	Class I	Active
EK III NH Fixture Pre-Mounted	AEK3S7013B	FDA UDI	Class II	Unknown
ET Convertible Combination Cylinder	ETCC4070TNCWH	FDA UDI	Class I	Active
Em Sa Implant (denture)	EMD2511S20	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICM4451H	FDA UDI	Class I	Active
Et Stud Abutment	ETSAM3550C	FDA UDI	Class II	Active
ET Multi Angled Abutment	ETMA317SHW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4751CWH	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETTIS4511NC	FDA UDI	Class I	Active
ET Rigid Abutment SET	ETRA5630CP	FDA UDI	Class II	Active
Et Rigid Lab Analog	ETRLA760C	FDA UDI	Class I	Active
ET Angled Abutment Set	ETAA4520ACWH	FDA UDI	Class II	Active
Et Ziocera Angled Abutment	ETZAA553SHW	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS6015AC	FDA UDI	Class I	Active
HG II Fixture Regular RBM Pre-Mounted	AHG2S4507R	FDA UDI	Class II	Active
ET III Fixture NH Mini D3.2Pre-Mounted	AET3M3010B	FDA UDI	Class II	Active
Ek Stud Abutment Normal	EKSA3560	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