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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 12 of 65

Device	Model / Reference	Registries	Class	Status
ET Transfer Abutment	ETTA7044SNW	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10UKRHW	FDA UDI	Class II	Active
Metal sleeve wide	HOGSCW35S	FDA UDI	Class I	Active
ET III SA Ultra-Wide Fixture No Mount	AET3R6013S	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI4011SN	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA4555MHW	FDA UDI	Class II	Active
ET IV NH Fixture Pre-Mounted	AET4R4007B	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S5510S	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI6011SH	FDA UDI	Class I	Active
HS II Fixture Mini RBM Pre-Mounted	AHS2M3515R18	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA5640P	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S4011B	FDA UDI	Class II	Active
ET III Fixture SA Mini [ Implant Only]	ET3M3513S	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4641HC	FDA UDI	Class I	Active
Et Freeform St Abutment Set	ETFA5030NCWH	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4510R28	FDA UDI	Class II	Active
Bite Impression Coping	ETBICR4451	FDA UDI	Class I	Active
EK III NH Fixture Pre-Mounted	AEK3S3511B	FDA UDI	Class II	Active
HG III Fixture RBM Mini Pre-Mounted	AHG3M3515R	FDA UDI	Class II	Active
HG II Ultra-Wide Fixture RBM Pre-Mounted	AHG2S7011R	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA6640TH	FDA UDI	Class II	Active
ET Rigid Burn-out Cylinder	ETRBC40B	FDA UDI	Class I	Active
ETIII SA (Ø3.2mm) No-mounted	CET3M3013S	FDA UDI	Class II	Active
Smartfit Et Mua Mn Et Mua Mini Non Hex	ETCMAMAMN	FDA UDI	Class I	Active
ET III Fixture NH Regular No-Mounted	CET3R4007B	FDA UDI	Class II	Active
A-Oss®A-graft®[Bone grafting material, Animal source]	HAS200SV	FDA UDI	Class II	Active
HG II Ultra-Wide Fixture RBM Pre-Mounted	AHG2S6011R	FDA UDI	Class II	Active
Ek Goldcast Abutment	EKGA4530NTH	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR5550HC	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA7610NCWH	FDA UDI	Class II	Active
ET cover screw Mini, Middle	ETCS35M	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4620CP	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4610P	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA5027SP	FDA UDI	Class II	Active
Ek Bite Index	EKBI4508S	FDA UDI	Class I	Active
EK III SA Fixture Pre-Mounted	AEK3S4007S	FDA UDI	Class II	Active
ET3 D5.5 NH No mount	CET3R5506B	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA7630NTH	FDA UDI	Class II	Active
ET IV NH Fixture No mount	CET4R4507B	FDA UDI	Class II	Active
HG III Fixture RBM Regular Pre-Mounted	AHG3S4513R	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA5720P	FDA UDI	Class II	Active
ET Multi Abutment	ETMTA501R	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4077MNW	FDA UDI	Class II	Active
Et Stud Abutment Set	ETSAO353S	FDA UDI	Class II	Active
ET Angled Abutment	ETAA6020NC	FDA UDI	Class II	Active
ET EsthTSic-low Gold Cylinder STS	ETMGR200CTH	FDA UDI	Class I	Active
ET Angled Abutment_A With EG Screw	ETAGA604SAW	FDA UDI	Class II	Active
Bite Impression Coping	ETBICR5620	FDA UDI	Class I	Active
EM Provisional	EMT18134	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA6440TH	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