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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 20 of 65

Device	Model / Reference	Registries	Class	Status
EK Hybrid Zirconia Abutment	EKHZ4061CHT	FDA UDI	Class II	Active
Et Bite Index	ETBIS5510S	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA4631NCWH	FDA UDI	Class II	Active
Smartfit Final Hybrid Denture - 4	FNLHYD04	FDA UDI	Class I	Active
ET Rigid Abutment SET	ETRA5740CP	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S7008S	FDA UDI	Class II	Active
ET II Fixture SA Regular Pre-Mounted	AET2R4515S	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETTIM4511NC	FDA UDI	Class I	Active
ET III NH Ultra-Wide Fixture Pre-Mount	AET3R6011B	FDA UDI	Class II	Active
HG III Ultra-Wide Fixture RBM Pre-Mounted	AHG3S6010R	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S6013B	FDA UDI	Class II	Active
ET III Fixture SA Regular [ Implant Only]	ET3R4511S	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA7420NTH	FDA UDI	Class II	Active
ET IV Fixture SA Regular No Mount	CET4R4011S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6014SNW	FDA UDI	Class II	Active
ET Convertible Abutment	ETCA4010CP	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4420P	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4651HC	FDA UDI	Class I	Active
ET Healing Abutment Regular, 5.3(D), 6.0(H)	ETHLA5006R	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4517MP	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4661HC	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA4622NTH	FDA UDI	Class II	Active
ET III Fixture BA Regular Pre-Mounted	AET3R5008B	FDA UDI	Class II	Active
Ek Fixture Transfer Impression Coping	EKTI6011N	FDA UDI	Class I	Active
ET Rigid Burn-out Cylinder	ETRBC70SB	FDA UDI	Class I	Active
Et Bite Index	ETBIS5506S	FDA UDI	Class I	Active
ET Multi Angled Abutment	ETMA317MHW	FDA UDI	Class II	Active
Et Rigid Retraction Cap	ETRRC660	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA4515SNW	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI6011SN	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA4017MNW	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR5460HC	FDA UDI	Class I	Active
EK III NH Fixture Pre-Mounted	AEK3S7006B	FDA UDI	Class II	Unknown
ET Transfer Abutment	ETTA6047SHW	FDA UDI	Class II	Active
Et Rigid Retraction Cap	ETRRC670C	FDA UDI	Class I	Active
Et Freeform St Abutment	ETFSA603SHW	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA12CERHW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4651CWH	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4013R18	FDA UDI	Class II	Active
ET III NH Ultra-Wide Fixture No-Mount	CET3R6008B	FDA UDI	Class II	Active
Et Goldcast Abutment	ETGCA453SHW	FDA UDI	Class II	Active
A-graft®[Bone grafting material, Animal source]	HAS025SV	FDA UDI	Class II	Active
HS II Fixture Wide RBM Pre-Mounted	AHS2W5013R20	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4537MNW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6015SNW	FDA UDI	Class II	Active
Ek Angled Abutment_a	EKAA4540ATH	FDA UDI	Class II	Active
HM Implant Denture	HMD2510R04	FDA UDI	Class II	Active
Ek Multi Abutment	EKMA5010P	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7045SHW	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S6010B	FDA UDI	Class II	Unknown

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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