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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 11 of 65

Device	Model / Reference	Registries	Class	Status
Bite Impression Coping	ETBICR4641	FDA UDI	Class I	Active
ET Pre-milled Abutment	ETPMA14ZKRHW	FDA UDI	Class II	Active
ET II Fixture SA Regular No-Mounted	CET2R4511S	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICM4421H	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIS5011NCA	FDA UDI	Class I	Active
Et Rigid Protect Cap	ETRPC6004S	FDA UDI	Class I	Active
ET Ebony Gold Cylinder Screw	ETFSRC	FDA UDI	Class I	Active
ET Temporary Abutment SET	ETTTA4010CTH	FDA UDI	Class II	Active
ET Gold Cast Abutment SET	ETGA4510SCWH	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS7011NAC	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTAS4631CWH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA6430CP	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI7011SH	FDA UDI	Class I	Active
HS II Fixture Mini RBM Pre-Mounted	AHS2M3515R28	FDA UDI	Class II	Active
EK Bite Impression Coping Hex	EKBIC4560H	FDA UDI	Class I	Active
Et Np-Cast Abutment	ETNCA453SNW	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA14MXMHW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5054SNW	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4630	FDA UDI	Class I	Active
ET Custom Healing Abutment	ETHLAP5R	FDA UDI	Class II	Active
ET Healing Abutment	ETHLA4005M	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S6011B	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4631CP	FDA UDI	Class II	Active
Et Goldcast Abutment	ETGCA453SNW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6065SNW	FDA UDI	Class II	Active
Et Pick-Up Guide Pin	ETFPG10SL	FDA UDI	Class I	Active
Et Fixture Transfer Impression Coping	ETTIS4514C	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIS7011CA	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA4712NTH	FDA UDI	Class II	Active
Ek Fixture Transfer Impression Coping	EKTI4511	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICM4461HC	FDA UDI	Class I	Active
EK III NH Fixture Pre-Mounted	AEK3S7007B	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4027MP	FDA UDI	Class II	Active
ET III Fixture NH Regular Pre-Mounted	AET3R4010B	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6025SNW	FDA UDI	Class II	Active
ET III Fixture NH Mini [ Implant Only ]	ET3M3511B	FDA UDI	Class II	Active
HS II Fixture Wide RBM Pre-Mounted	AHS2W4511R20	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICM4530H	FDA UDI	Class I	Active
ET III Fixture NH Regular [ Implant Only ]	ET3R5008B	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4612TH	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S3013B	FDA UDI	Class II	Active
Ek Stud Abutment Small	EKST3550	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4557MHW	FDA UDI	Class II	Active
Et Temporary Abutment	ETTPA453SNT	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR5540H	FDA UDI	Class I	Active
ET Convertible Transfer Imp. Coping	ETTIC480C	FDA UDI	Class I	Active
EK III SA Fixture Pre-Mounted	AEK3S6008S	FDA UDI	Class II	Unknown
EK III SA Fixture No Mount	CEK3S7011S	FDA UDI	Class II	Unknown
Smartfit Bone Reduction Guide 5 Holes	ETSGBR05	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA4731NTH	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