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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 7 of 65

Device	Model / Reference	Registries	Class	Status
EK Transfer Abutment	EKTA6410TH	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S5011B	FDA UDI	Class II	Active
ET Multi Combination Cylinder	ETMC500NCTH	FDA UDI	Class I	Active
EK Hybrid Zirconia Abutment	EKHZ4063CNT	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIM4015CA	FDA UDI	Class I	Active
Bite Impression Coping	ETBICR5430	FDA UDI	Class I	Active
ET III SA Ultra-Wide Fixture No Mount	CET3R6008S	FDA UDI	Class II	Active
ET Abutment Laboratory Screw	ETABSSLC	FDA UDI	Class I	Active
ET Angled Abutment Set	ETAA5020ACWH	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI4011SH	FDA UDI	Class I	Active
Et Stud Abutment	ETSAM3560C	FDA UDI	Class II	Active
HG II Ultra-Wide Fixture	CHG2S6010R	FDA UDI	Class II	Active
Esthetic-low Pick-Up Impression Coping Guide Pin	ETGP100	FDA UDI	Class I	Active
ET Pre-milled Abutment	ETPMA14ARMHW	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC5430	FDA UDI	Class I	Active
ET IV Fixture SA Regular Pre-Mounted	AET4R4013S	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4043CNT	FDA UDI	Class II	Active
ET3 D5.5 NH Pre-mounted	AET3R5508B	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5034SHW	FDA UDI	Class II	Active
ET Convertible Lab Analog	ETCLA600C	FDA UDI	Class I	Active
ET Rigid Abutment SET	ETRAS4451CP	FDA UDI	Class II	Active
EK cover screw Long	EKCS40L	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICM4540HC	FDA UDI	Class I	Active
Hiossen Ti Abutment Laboratory Screw	ETABSML	FDA UDI	Class I	Active
Em Sa Implant (denture)	EMD2510S40	FDA UDI	Class II	Active
Et Bite Index	ETBIS5504S	FDA UDI	Class I	Active
Bite Impression Coping	ETBICR4631	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA7065SHW	FDA UDI	Class II	Active
ET Healing Abutment	ETHLA5005R	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4527SNW	FDA UDI	Class II	Active
ET Convertible Combination Cylinder	ETCC5070TCWH	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIS7015NCA	FDA UDI	Class I	Active
ET Rigid Abutment SET	ETRA6620CP	FDA UDI	Class II	Active
ET II Fixture SA Regular Pre-Mounted	AET2R4008S	FDA UDI	Class II	Active
ET Temporary Abutment SET	ETTTA4530CTH	FDA UDI	Class II	Active
Ek Temporary Abutment	EKTTA4510NTH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4652TH	FDA UDI	Class II	Active
ET III Fixture SA Regular [ Implant Only]	ET3R4507S	FDA UDI	Class II	Active
A-graft®[Bone grafting material, Animal source]	HAS010LV	FDA UDI	Class II	Active
EK Freeform ST Abutment Straight 5.0(1.5), Hex	EKFAS5015TH	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA6035SP	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5034SNW	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA5047SP	FDA UDI	Class II	Active
EK Freeform ST Abutment 5.0(3.0), Hex	EKFA5030TH	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4562CHT	FDA UDI	Class II	Active
ET Convertible Temporary Cylinder Set	ETCTC400TNTHC	FDA UDI	Class I	Active
EK III SA Fixture No Mount	CEK3S4511S	FDA UDI	Class II	Active
Bite Impression Coping	ETBICR4651	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA7074SHW	FDA UDI	Class II	Active
ET Convertible Combination Cylinder	ETCC4070TCWH	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