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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 24 of 65

Device	Model / Reference	Registries	Class	Status
ET Bite Impression Coping	ETBICM4661HC	FDA UDI	Class I	Active
EK Onefit Abutment	EKCMAHT	FDA UDI	Class II	Active
Et Freeform St Abutment	ETFSA401SHW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4057MNW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5067SNW	FDA UDI	Class II	Active
ET Rigid Burn-out Cylinder	ET Rigid Burn-out Cylinder	FDA UDI	Class I	Active
ET Transfer Abutment	ETRGA7055SP	FDA UDI	Class II	Active
EK Fixture Pick up Guide pin	EKPGP150	FDA UDI	Class I	Active
ET III Fixture NH Mini D3.2 Pre-Mounted	AET3M3015B	FDA UDI	Class II	Active
Et Rigid Impression Coping	ETRIC4505S	FDA UDI	Class I	Active
ET Quick Temporary Abutment	ETQTA455MNT	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4721NTH	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4411P	FDA UDI	Class II	Active
Et Bite Index	ETBIM4510S	FDA UDI	Class I	Active
Et Rigid Lab Analog	ETRLA4505	FDA UDI	Class I	Active
Et Stud Abutment Set	ETSAO354S	FDA UDI	Class II	Active
ET Multi Abutment	ETMA5040CP	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S3007B	FDA UDI	Class II	Unknown
ETIII SA (Ø3.2mm) No-mounted	CET3M3011S	FDA UDI	Class II	Active
ET III Fixture NH Regular Pre-Mounted	AET3R4007B	FDA UDI	Class II	Active
ET Healing Abutment Regular, 6.3(D), 6.0(H)	ETHLA6006R	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S3508S	FDA UDI	Class II	Active
ET Healing Abutment	ETHLA4503M	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA5710CP	FDA UDI	Class II	Active
Et Bite Index	ETBIM4504SC	FDA UDI	Class I	Active
ET Angled Abutment Set	ETAA6020ACWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4671NCWH	FDA UDI	Class II	Active
ET IV NH Fixture No mount	CET4R5007B	FDA UDI	Class II	Active
ET Multi Abutment	ETMTA501M	FDA UDI	Class II	Active
ET Angled Abutment Set	ETAA4020MACWH	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4008R18	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4732NCWH	FDA UDI	Class II	Active
ET III Fixture NH Mini D3.2 No Mount	CET3M3015B	FDA UDI	Class II	Active
ET IV NH Ultra-Wide Fixture No mount	CET4R7013B	FDA UDI	Class II	Active
ET IV NH Fixture Pre-Mounted	AET4R4013B	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS6011NAC	FDA UDI	Class I	Active
Et Ziocera Abutment	ETZCA453MNW	FDA UDI	Class II	Active
ET III Fixture NH Regular [ Implant Only ]	ET3R4008B	FDA UDI	Class II	Active
EK Freeform ST Abutment 4.0(1.5), Hex	EKFA4015TH	FDA UDI	Class II	Active
ET Healing Abutment	ETHLA6004R	FDA UDI	Class II	Active
ET Convertible Temporary Cylinder	ETCTC500CWH	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIS6011NCA	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTAS4611CWH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA6420CP	FDA UDI	Class II	Active
HG II Fixture Regular RBM Pre-Mounted	AHG2S5013R	FDA UDI	Class II	Active
Et Rigid Retraction Cap	ETRRC440C	FDA UDI	Class I	Active
Et Rigid Retraction Cap	ETRRC760C	FDA UDI	Class I	Active
Et Fixture Transfer Impression Coping	ETFTI5017SH	FDA UDI	Class I	Active
Ek Multi Angled Abutment	EK17MA4830TH	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4621H	FDA UDI	Class I	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