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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 34 of 65

Device	Model / Reference	Registries	Class	Status
ET Transfer Abutment Set	ETTA5760NCWH	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S3010S	FDA UDI	Class II	Unknown
ET Angled Abutment	ETAA4540MAC	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICM4650HC	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICM4441HC	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA7035SP	FDA UDI	Class II	Active
A-graft®[Bone grafting material, Animal source]	HAS100LV	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA6630CP	FDA UDI	Class II	Active
ET EsthTSic-low Polishing Protector	ETMPCR100C	FDA UDI	Class I	Active
ET III Fixture SA Regular [ Implant Only]	ET3R4510S	FDA UDI	Class II	Active
ET Rigid Burn-out Cylinder	ETRP600BC	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA6740CWH	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S6011S	FDA UDI	Class II	Unknown
EK III SA Fixture Pre-Mounted	AEK3S5507S	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA6450NTH	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA6710P	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4541CNT	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S3510S	FDA UDI	Class II	Active
Bite Impression Coping (Mini)	ETBICM4640	FDA UDI	Class I	Active
Et Stud Abutment Set	ETSAO351S	FDA UDI	Class II	Active
Et Freeform St Abutment Set	ETFAS5030CWH	FDA UDI	Class II	Active
ETIII SA (Ø3.2mm) No-mounted	CET3M3015S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4037MNW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5440NCWH	FDA UDI	Class II	Active
ET IV NH Fixture Pre-Mounted	AET4R5011B	FDA UDI	Class II	Active
Multi Combination Cylinder	ETMC500NTH	FDA UDI	Class II	Active
Ek Stud Abutment Normal	EKSA3510	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R5011R18	FDA UDI	Class II	Active
ET III Fixture SA Regular Pre-Mounted	AET3R5013S	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR4531H	FDA UDI	Class I	Active
ET Multi Abutment	ETMTA503R	FDA UDI	Class II	Active
Ek Angled Abutment_b	EKAA5020BTH	FDA UDI	Class II	Active
ET Esthetic-low Temporary Cylinder Set	ETNMTR100CTH	FDA UDI	Class I	Active
ET3 D5.5 SA No mount	CET3R5508S	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA5034SP	FDA UDI	Class II	Active
HG II Fixture RBM Mini No Mount	CHG2M3508R	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4057MP	FDA UDI	Class II	Active
HS II Fixture Mini RBM Pre-Mounted	AHS2M3508R28	FDA UDI	Class II	Active
ET Multi Ti Base Screw	ETMTBSC	FDA UDI	Class I	Active
ET Rigid Abutment SET	ETRA5440CP	FDA UDI	Class II	Active
EK Pre-milled Abutment	EKPMA14MXNT	FDA UDI	Class II	Active
EK Digital Lab Analog Positioning For 3.5	EKDLA350	FDA UDI	Class I	Active
ET Convertible Plastic Cylinder	ETCPL500CWH	FDA UDI	Class I	Active
ET Bite Impression Coping Hex	ETBICM4641H	FDA UDI	Class I	Active
ET O-ring Lab Analog (Regular)	ETOAL	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA6035SHW	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA7450NTH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA7630CP	FDA UDI	Class II	Active
ET III Fixture NH Regular [ Implant Only ]	ET3R4010B	FDA UDI	Class II	Active
Et Stud Abutment Set	ETSAO354M	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