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 57 of 65

Device	Model / Reference	Registries	Class	Status
ET Rigid Abutment	ETRGA4047MP	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5710NCWH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA6450TH	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S7013B	FDA UDI	Class II	Unknown
Et Pick-Up Guide Pin	ETFPG05M	FDA UDI	Class I	Active
EK III NH Fixture Pre-Mounted	AEK3S4507B	FDA UDI	Class II	Active
Ek Fixture Pick-Up Impression Coping	EKPI6011N	FDA UDI	Class I	Active
ET Convertible Polishing Protector	ETCPC400C	FDA UDI	Class I	Active
ET III Fixture NH Regular [ Implant Only ]	ET3R4013B	FDA UDI	Class II	Active
HG III Fixture RBM Regular No Mount	CHG3S4507R	FDA UDI	Class II	Active
Em Sa Implant (narrow Ridge)	EMN2515S40	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA6450P	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S7013S	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR5640HC	FDA UDI	Class I	Active
HG III Ultra-Wide Fixture RBM Pre-Mounted	AHG3S7011R	FDA UDI	Class II	Active
Esthetic-low Temporary Abutment	ETMTW100TH	FDA UDI	Class I	Active
ET Healing Abutment	ETHLA4504R	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S3011S	FDA UDI	Class II	Unknown
ET IV Fixture SA Regular Pre-Mounted	AET4R4507S	FDA UDI	Class II	Active
ET III Fixture SA Mini No Mount	CET3M3513S	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI4511SH	FDA UDI	Class I	Active
Et Np-Cast Abutment	ETNCA403MNW	FDA UDI	Class II	Active
ET III Fixture SA Regular No Mount	CET3R5015S	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4450H	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA4652NCWH	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S6006S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6440CWH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4577MNW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4047MHW	FDA UDI	Class II	Active
ET Rigid Burn-out Cylinder	ETRP600SC	FDA UDI	Class I	Active
Esthetic-low Pick-Up Impression Coping Guide Pin	ETGPW100	FDA UDI	Class I	Active
ET IV Fixture SA Regular No Mount	CET4R4010S	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA6410NTH	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4451	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA5730TH	FDA UDI	Class II	Active
ET Angled Abutment_A With EG Screw	ETAGA434MAW	FDA UDI	Class II	Active
Et Rigid Retraction Cap	ETRRC670	FDA UDI	Class I	Active
ET II Fixture SA Regular Pre-Mounted	AET2R5015S	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10ZKRNW	FDA UDI	Class II	Active
ET III Fixture NH Regular [ Implant Only ]	ET3R5015B	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4420HC	FDA UDI	Class I	Active
EK III SA Fixture No Mount	CEK3S6007S	FDA UDI	Class II	Active
ET Healing Abutment	ETHLA4004M	FDA UDI	Class II	Active
HG II Fixture RBM Mini No Mount	CHG2M3515R	FDA UDI	Class II	Active
ET III NH Ultra-Wide Fixture Pre-Mount	AET3R6008B	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6620NCWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6670NCWH	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4035MP	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6017SHW	FDA UDI	Class II	Active
Et Rigid Retraction Cap	ETRRC570C	FDA UDI	Class I	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