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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 55 of 65

Device	Model / Reference	Registries	Class	Status
Bite Impression Coping (Mini)	ETBICM4431	FDA UDI	Class I	Active
Em Sa Implant (denture)	EMD2511S40	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4567SNW	FDA UDI	Class II	Active
ET III NH Ultra-Wide Fixture Pre-Mount	AET3R7008B	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI5020SH	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA6670CWH	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC5630H	FDA UDI	Class I	Active
EK III SA Fixture No Mount	CEK3S3010S	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICM4630HC	FDA UDI	Class I	Active
EK cover screw Middle	EKCS30M	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4661CWH	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10ANRHW	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S3511B	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5037SHW	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10MXRHW	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10UKRNW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4721CWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA7430CWH	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S4013S	FDA UDI	Class II	Active
Em Sa Implant (narrow Ridge)	EMN3011S25	FDA UDI	Class II	Active
ET Multi Ti Base	ETMTB0605	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6034SNW	FDA UDI	Class II	Active
ET Angled Abutment_A With EG Screw	ETAGA552SAW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7014SHW	FDA UDI	Class II	Active
ET III Fixture NH Regular Pre-Mounted	AET3R4510B	FDA UDI	Class II	Active
EK Pre-milled Abutment	EKPMA12CEHT	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S4013B	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S5011S	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S7010S	FDA UDI	Class II	Unknown
ET Convertible Angled Cylinder	ETAC4080TNCWH	FDA UDI	Class I	Active
ET Angled Abutment Set	ETAA6040BCWH	FDA UDI	Class II	Active
ET Multi Angled Abutment	ETMA417MHW	FDA UDI	Class II	Active
Em Sa Implant (denture)	EMD2008S20	FDA UDI	Class II	Active
Ek GOLDCAST ABUTMENT	EKGA4030NTH	FDA UDI	Class II	Active
ET III Fixture NH Regular No-Mounted	CET3R4507B	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R5007R18	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICM4521H	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA4527MNW	FDA UDI	Class II	Active
ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments	K253372	FDA 510(k)	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4015R28	FDA UDI	Class II	Active
ET Link Abutment(forCerec)Set(Regular)(Hex)	ETCTBRCWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4762NCWH	FDA UDI	Class II	Active
ET Ti Abutment Screw	ETABSMTC	FDA UDI	Class I	Active
EK III NH Fixture Pre-Mounted	AEK3S7011B	FDA UDI	Class II	Unknown
EK III SA Fixture Pre-Mounted	AEK3S7011S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5420NCWH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4577SHW	FDA UDI	Class II	Active
ET IV Fixture SA Ultra-Wide No Mount	CET4R6008S	FDA UDI	Class II	Active
Et Rigid Impression Coping	ETRIC5007S	FDA UDI	Class I	Active
ET II Fixture SA Regular No-Mounted	CET2R4015S	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