Is this your brand? Sign in to claim ownership.

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 40 of 65

Device	Model / Reference	Registries	Class	Status
EK III NH Fixture Pre-Mounted	AEK3S6007B	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4710CP	FDA UDI	Class II	Active
ET III Fixture SA Regular [ Implant Only]	ET3R4513S	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR5630H	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA4045MNW	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S4011S	FDA UDI	Class II	Active
ET III NH Ultra-Wide Fixture No-Mount	CET3R7011B	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4610CP	FDA UDI	Class II	Active
Ek Bite Index	EKBI4504S	FDA UDI	Class I	Active
ET IV Fixture SA Regular No Mount	CET4R4510S	FDA UDI	Class II	Active
ET III Fixture NH Regular No-Mounted	CET3R5008B	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA6450CP	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS5015NAC	FDA UDI	Class I	Active
ET III Fixture NH Regular Pre-Mounted	AET3R4008B	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4515MNW	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S6007S	FDA UDI	Class II	Unknown
ET Angled Abutment	ETAA6020AC	FDA UDI	Class II	Active
ET IV Fixture SA Ultra-Wide No Mount	CET4R7013S	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4547MP	FDA UDI	Class II	Active
ET II Fixture SA Regular No-Mounted	CET2R4508S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5054SHW	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC5650H	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA6047SP	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6077SHW	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S6006S	FDA UDI	Class II	Unknown
EK Freeform ST Abutment 6.0(1.5), Hex	EKFA6015TH	FDA UDI	Class II	Active
EK Pre-milled Abutment	EKPMA12CENT	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5017SNW	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S5510B	FDA UDI	Class II	Active
ET III Fixture BA Regular Pre-Mounted	AET3R5007B	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6037SHW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5450NCWH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5055SHW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4565MNW	FDA UDI	Class II	Active
ET II Fixture SA Regular Pre-Mounted	AET2R4015S	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA6740TH	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA6750P	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4017MHW	FDA UDI	Class II	Active
ET Angled Abutment	ETAA4040MNC	FDA UDI	Class II	Active
ET Angled Abutment	ETAA4040MBC	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S5010B	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4441CP	FDA UDI	Class II	Active
ET Healing Abutment	ETHLA6007R	FDA UDI	Class II	Active
ET Healing Abutment Mini, 4.3(D), 6.0(H)	ETHLA4006M	FDA UDI	Class II	Active
Ek Stud Abutment Small	EKST3540	FDA UDI	Class II	Active
HG III Fixture RBM Mini No Mount	CHG3M3511R	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S7010B	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S7008B	FDA UDI	Class II	Active
Em Sa Implant (narrow Ridge)	EMN3010S40	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA7610TH	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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