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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 18 of 65

Device	Model / Reference	Registries	Class	Status
HM Implant Denture	HMD3013R02	FDA UDI	Class II	Active
ET Esthetic-low Healing Cap	ETMHCR100C	FDA UDI	Class I	Active
Et Ziocera Abutment	ETZCA555SHW	FDA UDI	Class II	Active
ET III SA Ultra-Wide Fixture No Mount	CET3R7011S	FDA UDI	Class II	Active
ET III Fixture SA Regular No Mount	CET3R4015S	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4451P	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S7011S	FDA UDI	Class II	Active
ET Custom Healing Abutment	ETHLAP7R	FDA UDI	Class II	Active
HM Implant Denture	HMD2515R04	FDA UDI	Class II	Active
ETIII SA (Ø3.2mm) No-mounted	CET3M3010S	FDA UDI	Class II	Active
ET III Fixture NH Mini Pre-Mounted	AET3M3515B	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA6740NTH	FDA UDI	Class II	Active
Esthetic-low Gold Cylinder	ETMGR200TH	FDA UDI	Class I	Active
HG III Ultra-Wide Fixture RBM Pre-Mounted	AHG3S6013R	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA7650P	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S5007S	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICM4531HC	FDA UDI	Class I	Active
ET III SA Ultra-Wide Fixture Pre-Mounted	AET3R6006S	FDA UDI	Class II	Active
HM Implant Narrow Ridge	HMN3013R04	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4631CP	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS6015NCA	FDA UDI	Class I	Active
EK III NH Fixture Pre-Mounted	AEK3S6013B	FDA UDI	Class II	Unknown
HM Implant Denture	HMD3010R04	FDA UDI	Class II	Active
ET III SA Ultra-Wide Fixture Pre-Mounted	AET3R7011S	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR4461H	FDA UDI	Class I	Active
Et Rigid Impression Coping	ETRIC461SC	FDA UDI	Class I	Active
ET II Fixture SA Mini No-Mounted	CET2M3518S	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA5015SP	FDA UDI	Class II	Active
HS II Fixture Mini RBM Pre-Mounted	AHS2M3510R28	FDA UDI	Class II	Active
ETIII SA (Ø3.2mm) Pre-mounted	AET3M3015S	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S6010B	FDA UDI	Class II	Active
ET III Fixture BA Mini Pre-Mounted	AET3M3515B	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S5007B	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4651CWH	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR5520H	FDA UDI	Class I	Active
EK Scan body (Short)	EKSBOS	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETFPI4011MN	FDA UDI	Class I	Active
EK III NH Fixture No Mount	CEK3S7011B	FDA UDI	Class II	Active
ET III Fixture NH Regular Pre-Mounted	AET3R4011B	FDA UDI	Class II	Active
ET IV Fixture SA Ultra-Wide Pre-Mounted	AET4R6010S	FDA UDI	Class II	Active
ET Convertible Plastic Cylinder	ETCPL400NCWH	FDA UDI	Class I	Active
ET II Fixture SA Regular No-Mounted	CET2R5011S	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA5045SP	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6610CWH	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4545SP	FDA UDI	Class II	Active
ET III Fixture SA Mini [ Implant Only]	ET3M3511S	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR5430H	FDA UDI	Class I	Active
HG III Fixture RBM Regular No Mount	CHG3S5015R	FDA UDI	Class II	Active
EK Fixture Pick up Guide pin	EKPGP100	FDA UDI	Class I	Active
ET Scan body(Intraoral)	ETNSBRSTH	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