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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 31 of 65

Device	Model / Reference	Registries	Class	Status
HS II Fixture Wide RBM Pre-Mounted	AHS2W4510R20	FDA UDI	Class II	Active
ET III Fixture NH Regular No-Mounted	CET3R4508B	FDA UDI	Class II	Active
ET II Fixture SA Regular No-Mounted	CET2R5013S	FDA UDI	Class II	Active
ET III Fixture SA Regular No Mount	CET3R4008S	FDA UDI	Class II	Active
Et Ziocera Abutment	ETZCA455MNW	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10ARRNW	FDA UDI	Class II	Active
EK cover screw Long	EKCS35L	FDA UDI	Class II	Active
Ek Stud Abutment Normal	EKSA3530	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7610CWH	FDA UDI	Class II	Active
A-Oss®	AOSN025LV	FDA UDI	Class II	Unknown
HS II Fixture Regular RBM Pre-Mounted	AHS2R5015R18	FDA UDI	Class II	Active
ET III Fixture SA Regular Pre-Mounted	AET3R4515S	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC5450H	FDA UDI	Class I	Active
ET IV Fixture SA Ultra-Wide No Mount	CET4R7007S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA7410CWH	FDA UDI	Class II	Active
ET Healing Abutment	ETHLA5007R	FDA UDI	Class II	Active
ET Esthetic-low Temporary Cylinder Set	ETMTR100CTH	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA4035MHW	FDA UDI	Class II	Active
Esthetic-low Gold Cylinder	ETMGW100TH	FDA UDI	Class I	Active
ET Pre-milled Abutment	ETPMA14CARNW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4077MHW	FDA UDI	Class II	Active
Ek Np-Cast Abutment	EKNA4530TH	FDA UDI	Class II	Active
Ek Fixture Pick-Up Impression Coping	EKPI6016	FDA UDI	Class I	Active
ET Angled Abutment_B With EG Screw	ETAGA552SBW	FDA UDI	Class II	Active
ET III Fixture NH Regular No-Mounted	CET3R4013B	FDA UDI	Class II	Active
ET Rigid Burn-out Cylinder	ETRP400BC	FDA UDI	Class I	Active
Hiossen	AET3M3015S	FDA UDI	Class II	Active
Ek Goldcast Abutment	EKGA4010TH	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR5440HC	FDA UDI	Class I	Active
Em Sa Implant (denture)	EMD3013S20	FDA UDI	Class II	Active
ET III NH Ultra-Wide Fixture No-Mount	CET3R6006B	FDA UDI	Class II	Active
HG II Fixture RBM Regular No Mount	CHG2S4013R	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4651	FDA UDI	Class I	Active
ET Custom Healing Abutment	ETHLAP5M	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4420	FDA UDI	Class I	Active
EK III SA Fixture No Mount	CEK3S5511S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6770NCWH	FDA UDI	Class II	Active
ET Angled Abutment Set	ETAA4040MBCWH	FDA UDI	Class II	Active
HG III Fixture RBM Regular Pre-Mounted	AHG3S5007R	FDA UDI	Class II	Active
ET II Fixture SA Mini Pre-Mounted	AET2M3510S	FDA UDI	Class II	Active
ET III Fixture NH Regular [ Implant Only ]	ET3R5007B	FDA UDI	Class II	Active
HM Implant Narrow Ridge	HMN3015R04	FDA UDI	Class II	Active
Hiossen EbonyGold Abutment Screw	ETABSM	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA6015SHW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4027MHW	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4421P	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4575MNW	FDA UDI	Class II	Active
ET III Fixture SA Regular [ Implant Only]	ET3R4013S	FDA UDI	Class II	Active
ET Multi Angled Abutment	ET30MAS4840CWH	FDA UDI	Class II	Active
ET Angled Abutment	ETAA5040NC	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