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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 36 of 65

Device	Model / Reference	Registries	Class	Status
EK Hybrid Zirconia Abutment	EKHZ4042OHT	FDA UDI	Class II	Active
ET Convertible Temporary Cylinder	ETCTC400TCTH	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICM4640HC	FDA UDI	Class I	Active
Bite Impression Coping (Mini)	ETBICM4440	FDA UDI	Class I	Active
ET Rigid Burn-out Cylinder	ETRP450BC	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA5740TH	FDA UDI	Class II	Active
Et Rigid Retraction Cap	ETRRC570	FDA UDI	Class I	Active
HG II Ultra-Wide Fixture	CHG2S7008R	FDA UDI	Class II	Active
ET III Fixture NH Regular No-Mounted	CET3R5010B	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4450P	FDA UDI	Class II	Active
ET Convertible Abutment	ETCA4040CP	FDA UDI	Class II	Active
Et Stud Abutment	ETSAO355S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4732CWH	FDA UDI	Class II	Active
Ek Angled Abutment(n)	EKAA4540NTH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4067MHW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5660CWH	FDA UDI	Class II	Active
ET IV Fixture SA Regular No Mount	CET4R4511S	FDA UDI	Class II	Active
Et Stud Abutment	ETSA3540C	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA6630NTH	FDA UDI	Class II	Active
ET III Fixture NH Regular No-Mounted	CET3R4015B	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S3513S	FDA UDI	Class II	Active
Ek Multi Abutment	EKMA5020P	FDA UDI	Class II	Active
Et Rigid Impression Coping	ETRIC6007S	FDA UDI	Class I	Active
ET Multi Angled Abutment	ET30MAS4830CWH	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S7006S	FDA UDI	Class II	Unknown
ET Esthetic-low Plastic Cylinder	ETMEPR200CTH	FDA UDI	Class I	Active
Smartfit Bone Reduction Guide 6 Holes	ETSGBR06	FDA UDI	Class I	Active
Et Rigid Lab Analog	ETRLA4507	FDA UDI	Class I	Active
ET Angled Abutment	ETAA4520MBC	FDA UDI	Class II	Active
ET cover screw Mini	ETCS35	FDA UDI	Class II	Active
Martfit Bone Reduction Guide9 Holes	ETSGBR09	FDA UDI	Class I	Active
EK III SA Fixture Pre-Mounted	AEK3S5511S	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA6430P	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S6008S	FDA UDI	Class II	Unknown
ET IV NH Fixture No mount	CET4R4008B	FDA UDI	Class II	Active
ET Angled Abutment Set	ETAA4520NCWH	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4551HC	FDA UDI	Class I	Active
EK III SA Fixture Pre-Mounted	AEK3S5010S	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETTIS5014NC	FDA UDI	Class I	Active
ET Bite Impression Coping Hex	ETBICM4661H	FDA UDI	Class I	Active
ET III Fixture NH Mini No-Mounted	CET3M3515B	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR4431H	FDA UDI	Class I	Active
ET Link Abutment(for Cerec)Set (Mini)(Hex)	ETCTBMCWH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA6630TH	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA6620P	FDA UDI	Class II	Active
ET Convertible Angled Cylinder	ET17CC5080CWH	FDA UDI	Class I	Active
EK III NH Fixture No Mount	CEK3S3013B	FDA UDI	Class II	Unknown
ET Multi Angled Abutment	ET30MAM4830CWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA7440NCWH	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICM4560H	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