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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 54 of 65

Device	Model / Reference	Registries	Class	Status
ET Multi Angled Abutment	ET17MAM4840CWH	FDA UDI	Class II	Active
ET III Fixture SA Regular No Mount	CET3R4507S	FDA UDI	Class II	Active
Ek Stud Abutment Small	EKST3520	FDA UDI	Class II	Active
ET II Fixture SA Mini Pre-Mounted	AET2M3508S	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4431H	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA4752NTH	FDA UDI	Class II	Active
ET Bite Impression Coping Hex ET Bite Impression Coping Hex	ETBICR5640H	FDA UDI	Class I	Active
ET3 D5.5 SA Pre-mounted	AET3R5513S	FDA UDI	Class II	Active
ET IV Fixture SA Ultra-Wide Pre-Mounted	AET4R6008S	FDA UDI	Class II	Active
Et Rigid Impression Coping	ETRIC7005S	FDA UDI	Class I	Active
ET Bite Impression Coping Hex	ETBICR5450H	FDA UDI	Class I	Active
ET Bite Impression Coping Hex	ETBICM4450H	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA4621NTH	FDA UDI	Class II	Active
Ek Angled Abutment(n)	EKAA4040NTH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5450TH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4557SNW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4711NCWH	FDA UDI	Class II	Active
Et Rigid Lab Analog	ETRLA4007	FDA UDI	Class I	Active
Et Goldcast Abutment	ETGCA403MNW	FDA UDI	Class II	Active
HG II Fixture Mini RBM Pre-Mounted	AHG2M3510R	FDA UDI	Class II	Active
ET III Fixture NH Regular No-Mounted	CET3R4513B	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA6720P	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4651NCWH	FDA UDI	Class II	Active
HM Implant Denture	HMD3015R04	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4721CWH	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI6015SH	FDA UDI	Class I	Active
Et Np-Cast Abutment	ETNCA401MNW	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4620HC	FDA UDI	Class I	Active
Ek Angled Abutment_a	EKAA5020ATH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6610NCWH	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR5530H	FDA UDI	Class I	Active
ET Digital Lab Analog Screw	ETDLAS	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA5630CWH	FDA UDI	Class II	Active
HG II Fixture Mini RBM Pre-Mounted	AHG2M3511R	FDA UDI	Class II	Active
ET II Fixture SA Regular Pre-Mounted	AET2R4011S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4547MNW	FDA UDI	Class II	Active
Bite Impression Coping	ETBICR5420	FDA UDI	Class I	Active
ET III SA Ultra-Wide Fixture No Mount	CET3R6011S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4671NCWH	FDA UDI	Class II	Active
Et O-Ring	ETOAON02SC	FDA UDI	Class I	Active
ET Temporary Abutment SET	ETTTA4530NCTH	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4640HC	FDA UDI	Class I	Active
ET Angled Abutment_A With EG Screw	ETAGA454SAW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA7420CWH	FDA UDI	Class II	Active
ET Angled Abutment Set	ETAA4520MNCWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4751NCWH	FDA UDI	Class II	Active
ET IV Fixture SA Ultra-Wide No Mount	CET4R7011S	FDA UDI	Class II	Active
ET Fixture Pick-up Impression Coping	ETPIM4511CA	FDA UDI	Class I	Active
Et Np-Cast Abutment	ETNCA453SHW	FDA UDI	Class II	Active
ET II Fixture SA Regular No-Mounted	CET2R5010S	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