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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 28 of 65

Device	Model / Reference	Registries	Class	Status
Et Fixture Pick-Up Impression Coping	ETPIS7015AC	FDA UDI	Class I	Active
ET3 D5.5 SA Pre-mounted	AET3R5511S	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4547SP	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S4008B	FDA UDI	Class II	Active
Ek Multi Angled Abutment Screw	EKMAABST	FDA UDI	Class I	Active
HG III Fixture RBM Regular No Mount	CHG3S4508R	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S5008S	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4560HC	FDA UDI	Class I	Active
O-ring Retainer Cap	ETRCS01C	FDA UDI	Class I	Active
EK III SA Fixture No Mount	CEK3S6008S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5065SHW	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S3008B	FDA UDI	Class II	Unknown
ET Transfer Abutment Set	ETTA4751NCWH	FDA UDI	Class II	Active
ET III Fixture SA Regular Pre-Mounted	AET3R4015S	FDA UDI	Class II	Active
Et Ziocera Abutment	ETZCA655SHW	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR5560HC	FDA UDI	Class I	Active
EK III SA Fixture No Mount	CEK3S6013S	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4564CHT	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S3010B	FDA UDI	Class II	Unknown
ET Convertible Abutment	ETCA6040CP	FDA UDI	Class II	Active
ET Gold Cast Abutment SET	ETGA4530SCWH	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIM4011AC	FDA UDI	Class I	Active
ET Laboratory Screw	ETABSMLC	FDA UDI	Class I	Active
HG II Fixture RBM Regular No Mount	CHG2S5011R	FDA UDI	Class II	Active
HM Implant Denture	HMD2513R02	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4731CWH	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS4015NAC	FDA UDI	Class I	Active
EK Bite Impression Coping	EKBIC5620	FDA UDI	Class I	Active
HG III Fixture RBM Regular No Mount	CHG3S4513R	FDA UDI	Class II	Active
ET Healing Abutment	ETHLA6003R	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA5750P	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4450CP	FDA UDI	Class II	Active
Ek Fixture Transfer Impression Coping	EKTI6011	FDA UDI	Class I	Active
Esthetic-low Healing Cap	ETMHCR100	FDA UDI	Class I	Active
ET Angled Abutment Set	ETAA4540BCWH	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI4015MH	FDA UDI	Class I	Active
ET Angled Abutment	ETAA4540NC	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6730NCWH	FDA UDI	Class II	Active
Et Ziocera Abutment	ETZCA453MHW	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA6440CP	FDA UDI	Class II	Active
ETIII SA (Ø3.2mm) [ Implant Only ]	ET3M3010S	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S3011B	FDA UDI	Class II	Active
ET III NH Ultra-Wide Fixture Pre-Mount	AET3R7006B	FDA UDI	Class II	Active
HG III Ultra-Wide Fixture RBM Pre-Mounted	AHG3S7008R	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5610TH	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S7010S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4515SHW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5460NCWH	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA14ARRNW	FDA UDI	Class II	Active
HG III Fixture RBM Regular No Mount	CHG3S4015R	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