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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 10 of 65

Device	Model / Reference	Registries	Class	Status
Et Fixture Transfer Impression Coping	ETFTI4514SH	FDA UDI	Class I	Active
ET Healing Abutment	ETHLA5003R	FDA UDI	Class II	Active
HM Implant Denture	HMD3010R02	FDA UDI	Class II	Active
ET III Fixture NH Mini Pre-Mounted	AET3M3510B	FDA UDI	Class II	Active
Et Rigid Protect Cap	ETRPC670C	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA4017SP	FDA UDI	Class II	Active
ET III Fixture NH Regular No-Mounted	CET3R4510B	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R5008R28	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S4007S	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR4651H	FDA UDI	Class I	Active
EK Hybrid Zirconia Abutment	EKHZ4041CNT	FDA UDI	Class II	Active
HG II Fixture Regular RBM Pre-Mounted	AHG2S5007R	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5770NCWH	FDA UDI	Class II	Active
Smartfit Final Hybrid Denture - 6	FNLHYD06	FDA UDI	Class I	Active
Et Rigid Retraction Cap	ETRRC470	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA4721TH	FDA UDI	Class II	Active
Et Rigid Impression Coping	ETRIC6005S	FDA UDI	Class I	Active
EK III SA Fixture Pre-Mounted	AEK3S4010S	FDA UDI	Class II	Active
Em Sa Implant (narrow Ridge)	EMN3010S25	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S7013S	FDA UDI	Class II	Unknown
ET cover screw Mini	ETCSMS	FDA UDI	Class II	Active
EK Onefit Abutment(Gold)	EKCMAHCT	FDA UDI	Class II	Active
ET Multi Angled Abutment	ET30MAM4840CWH	FDA UDI	Class II	Active
Em Sa Implant (denture)	EMD2510S20	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4057SP	FDA UDI	Class II	Active
ET IV Fixture SA Regular Pre-Mounted	AET4R4011S	FDA UDI	Class II	Active
ET Ti Abutment Screw	ETABSSTC	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA4024SP	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI4515MN	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA7620NCWH	FDA UDI	Class II	Active
HG III Fixture RBM Mini Pre-Mounted	AHG3M3510R	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6034SHW	FDA UDI	Class II	Active
ET III Fixture SA Regular No Mount	CET3R4011S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA7630NCWH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA5430CP	FDA UDI	Class II	Active
Et Stud Abutment	ETSAO353M	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4017MP	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6044SHW	FDA UDI	Class II	Active
ET IV Fixture SA Regular Pre-Mounted	AET4R5011S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5410CWH	FDA UDI	Class II	Active
Et Rigid Protect Cap	ETRPC760C	FDA UDI	Class I	Active
ET Pre-milled Abutment	ETPMA14ZKRNW	FDA UDI	Class II	Active
ET Angled Abutment(N) With EG Screw	ETAGA602SNW	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S6010S	FDA UDI	Class II	Unknown
Et Fixture Transfer Impression Coping	ETFTI5017SN	FDA UDI	Class I	Active
HySil Light	ESS50L	FDA UDI	Class II	Active
Bite Impression Coping	ETBICR4441	FDA UDI	Class I	Active
ET Convertible Pick-up Guide Pin	ETCGP400LC	FDA UDI	Class I	Active
ET Angled Abutment	ETAA6040BC	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS7015CA	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