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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: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3007135442
DUNS Number: —

Catalogue (3217)

Page 17 of 65

Device	Model / Reference	Registries	Class	Status
HG III Fixture RBM Mini Pre-Mounted	AHG3M3511R	FDA UDI	Class II	Active
Em Sa Implant (denture)	EMD2015S20	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6074SNW	FDA UDI	Class II	Active
Et Rigid Lab Analog	ETRLA6005S	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA5640NCWH	FDA UDI	Class II	Active
ET IV Fixture SA Ultra-Wide Pre-Mounted	AET4R7013S	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI6011SN	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA7075SHW	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA6440NTH	FDA UDI	Class II	Active
ET IV NH Fixture Pre-Mounted	AET4R4508B	FDA UDI	Class II	Active
Et Freeform St Abutment	ETFSA403SHW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6660NCWH	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA5044SP	FDA UDI	Class II	Active
EK Bite Impression Coping Hex	EKBIC4531H	FDA UDI	Class I	Active
ET Stud abutment	ETSAO351M	FDA UDI	Class II	Active
ET Angled Abutment Set	ETAA6020NCWH	FDA UDI	Class II	Active
EK Fixture Pick up Guide pin	EKPGP250	FDA UDI	Class I	Active
EK III SA Fixture No Mount	CEK3S6010S	FDA UDI	Class II	Unknown
Et O-Ring Retainer Cap	ETOARC02C	FDA UDI	Class I	Active
EK Hybrid Zirconia Abutment	EKHZ4542ONT	FDA UDI	Class II	Active
ETIII SA (Ø3.2mm) No-mounted	CET3M3008S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7055SHW	FDA UDI	Class II	Active
Ek Goldcast Abutment	EKGA4030TH	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4562CNT	FDA UDI	Class II	Active
Et Stud Abutment Set	ETSAO356S	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIM4515CA	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA4047SP	FDA UDI	Class II	Active
Et Bite Index	ETBIM4512S	FDA UDI	Class I	Active
EK Hybrid Zirconia Abutment	EKHZ4041OHT	FDA UDI	Class II	Active
ET III Fixture NH Mini No-Mounted	CET3M3513B	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA5014SP	FDA UDI	Class II	Active
ET Convertible Abutment	ETCA5040CP	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S5513B	FDA UDI	Class II	Active
Et Rigid Lab Analog	ETRLA670C	FDA UDI	Class I	Active
ET III Fixture NH Regular No-Mounted	CET3R4008B	FDA UDI	Class II	Active
ET Link Abutment	ETCTBRHW	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI7014SN	FDA UDI	Class I	Active
ET Healing Abutment	ETHLA4505R	FDA UDI	Class II	Active
ET III Fixture SA Regular Pre-Mounted	AET3R4013S	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S5013S	FDA UDI	Class II	Active
ET III Fixture NH Regular No-Mounted	CET3R4515B	FDA UDI	Class II	Active
Multi Combination Cylinder	ETMC500TH	FDA UDI	Class II	Active
ET Convertible Temporary Cylinder Set	ETCTC400TTHC	FDA UDI	Class I	Active
EK III SA Fixture No Mount	CEK3S5513S	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S5513S	FDA UDI	Class II	Active
ET III Fixture SA Regular [ Implant Only]	ET3R5008S	FDA UDI	Class II	Active
ET III Fixture BA Regular Pre-Mounted	AET3R4013B	FDA UDI	Class II	Active
Et Freeform St Abutment Set	ETFA4030NCWH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4527MHW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7015SHW	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