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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 23 of 65

Device	Model / Reference	Registries	Class	Status
ET Transfer Abutment Set	ETTA5640CWH	FDA UDI	Class II	Active
Et Ziocera Angled Abutment	ETZAA654SHW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4762CWH	FDA UDI	Class II	Active
ET III Fixture NH Regular Pre-Mounted	AET3R5011B	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4621NCWH	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS4511AC	FDA UDI	Class I	Active
EK Pre-milled Abutment	EKPMA10MXHT	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICM4660HC	FDA UDI	Class I	Active
HG II Ultra-Wide Fixture RBM Pre-Mounted	AHG2S7010R	FDA UDI	Class II	Active
ET Angled Abutment	ETAA4020MNC	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S4511B	FDA UDI	Class II	Active
ET IV NH Ultra-Wide Fixture Pre-Mounted	AET4R7010B	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4542OHT	FDA UDI	Class II	Active
EK Healing Abutment	EKHA703	FDA UDI	Class II	Active
Et O-Ring Retainer	ETOARCC	FDA UDI	Class I	Active
ET Multi Angled Abutment	ETMA417SHW	FDA UDI	Class II	Active
ET IV NH Ultra-Wide Fixture No mount	CET4R6008B	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5064SHW	FDA UDI	Class II	Active
ET II Fixture SA Regular No-Mounted	CET2R5008S	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4061CNT	FDA UDI	Class II	Active
Em Sa Implant (denture)	EMD3011S20	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4712CWH	FDA UDI	Class II	Active
HS II Fixture Mini RBM Pre-Mounted	AHS2M3511R18	FDA UDI	Class II	Active
ET II Fixture SA Regular No-Mounted	CET2R4513S	FDA UDI	Class II	Active
3d Lab Analog	ETFLAS3D	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIS4011AC	FDA UDI	Class I	Active
HG II Fixture Regular RBM Pre-Mounted	AHG2S5015R	FDA UDI	Class II	Active
Hiossen	AET3M3010S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6750NCWH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA5420CP	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S4513B	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S4010S	FDA UDI	Class II	Active
Em Sa Implant (denture)	EMD3008S40	FDA UDI	Class II	Active
Ek Np-Cast Abutment	EKNA4510TH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7034SHW	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR4421H	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA7640NCWH	FDA UDI	Class II	Active
Smartfit Try In Hybrid Denture - 7	TRYHYD07	FDA UDI	Class I	Active
ET III Fixture SA Regular No Mount	CET3R4510S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA7660NCWH	FDA UDI	Class II	Active
ET Multi Abutment	ETMA5030MCP	FDA UDI	Class II	Active
ET Quick Temporary Abutment	ETQTA405MHT	FDA UDI	Class II	Active
ET III Fixture NH Regular [ Implant Only ]	ET3R5011B	FDA UDI	Class II	Active
ET IV NH Fixture No mount	CET4R4510B	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7075SNW	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S4013S	FDA UDI	Class II	Active
ET Multi Ti Base	ETMTB0410	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7074SNW	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA6630P	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4441HC	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