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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 51 of 65

Device	Model / Reference	Registries	Class	Status
Et Fixture Pick-Up Impression Coping	ETFPI4015MN	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICR5420HC	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA4721NCWH	FDA UDI	Class II	Active
ET Convertible Lab Analog	ETCLA500C	FDA UDI	Class I	Active
ET Bite Impression Coping Hex	ETBICM4460H	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICR4520HC	FDA UDI	Class I	Active
ET Angled Abutment_A With EG Screw	ETAGA452MAW	FDA UDI	Class II	Active
Et Rigid Lab Analog	ETRLA660C	FDA UDI	Class I	Active
ET Bite Impression Coping Hex	ETBICR5440H	FDA UDI	Class I	Active
ET III Fixture NH Regular [ Implant Only ]	ET3R5013B	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S3013S	FDA UDI	Class II	Unknown
ET Transfer Abutment Set	ETTA6640CWH	FDA UDI	Class II	Active
Et Rigid Lab Analog	ETRLA570C	FDA UDI	Class I	Active
EK Pre-milled Abutment	EKPMA10CAHT	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6750CWH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4652NTH	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S3013S	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA5410P	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETTIS7014C	FDA UDI	Class I	Active
ET III Fixture SA Regular Pre-Mounted	AET3R4507S	FDA UDI	Class II	Active
ETIII SA (Ø3.2mm) Pre-mounted	AET3M3013S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6450NCWH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4740CP	FDA UDI	Class II	Active
HG II Fixture Mini RBM Pre-Mounted	AHG2M3508R	FDA UDI	Class II	Active
ET FIXTURE PICK-UP IMPRESSION COPING Regular Hex	ETFTI5017SH	FDA UDI	Class I	Active
HG II Fixture Regular RBM Pre-Mounted	AHG2S4007R	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4555SP	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5064SNW	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI5011SN	FDA UDI	Class I	Active
Et Rigid Lab Analog	ETRLA441C	FDA UDI	Class I	Active
Et Fixture Transfer Impression Coping	ETFTI4020MH	FDA UDI	Class I	Active
ET III NH Ultra-Wide Fixture No-Mount	CET3R7010B	FDA UDI	Class II	Active
ET II Fixture SA Regular Pre-Mounted	AET2R4007S	FDA UDI	Class II	Active
HG II Fixture Regular RBM Pre-Mounted	AHG2S4015R	FDA UDI	Class II	Active
EK Freeform ST Abutment 4.0(3.0), Hex	EKFA4030TH	FDA UDI	Class II	Active
HS II Fixture Mini RBM Pre-Mounted	AHS2M3511R28	FDA UDI	Class II	Active
ET III SA Ultra-Wide Fixture Pre-Mounted	AET3R7008S	FDA UDI	Class II	Active
Et Rigid Impression Coping	ETRIC660SC	FDA UDI	Class I	Active
ET Angled Abutment	ETAA6040NC	FDA UDI	Class II	Active
Et Freeform St Abutment Set	ETFA5015CWH	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4011R18	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4025MHW	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5450NTH	FDA UDI	Class II	Active
ETIII SA (Ø3.2mm) Pre-mounted	AET3M3010S	FDA UDI	Class II	Active
ET III NH Ultra-Wide Fixture No-Mount	CET3R6010B	FDA UDI	Class II	Active
ET III Fixture SA Regular No Mount	CET3R5013S	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S5507S	FDA UDI	Class II	Active
HS II Fixture Wide RBM Pre-Mounted	AHS2W4513R20	FDA UDI	Class II	Active
Metal sleeve wide	HOGSCW50S	FDA UDI	Class I	Active
Ek Rigid Abutment	EKRA4430P	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