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 32 of 65

Device	Model / Reference	Registries	Class	Status
ET Transfer Abutment Set	ETTA6650CWH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4431CP	FDA UDI	Class II	Active
EK Bite Impression Coping Hex	EKBIC4660H	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA5430NTH	FDA UDI	Class II	Active
ET Esthetic-low Temporary Cylinder Set	ETNMTR200CTH	FDA UDI	Class I	Active
ET IV Fixture SA Regular Pre-Mounted	AET4R4510S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5015SHW	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI5011SN	FDA UDI	Class I	Active
ET III Fixture BA Regular Pre-Mounted	AET3R4010B	FDA UDI	Class II	Active
ET IV Fixture SA Regular No Mount	CET4R4013S	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4630CP	FDA UDI	Class II	Active
Ek Fixture Pick-Up Impression Coping	EKPI5011	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIS5015CA	FDA UDI	Class I	Active
Em Sa Implant (narrow Ridge)	EMN2511S25	FDA UDI	Class II	Active
HG III Fixture RBM Regular Pre-Mounted	AHG3S4015R	FDA UDI	Class II	Active
ET Angled Abutment(N) With EG Screw	ETAGA452MNW	FDA UDI	Class II	Active
ET II Fixture SA Mini No-Mounted	CET2M3510S	FDA UDI	Class II	Active
ET III Fixture SA Regular No Mount	CET3R5011S	FDA UDI	Class II	Active
Ek Stud Abutment Normal	EKSA3550	FDA UDI	Class II	Active
Ek GOLDCAST ABUTMENT	EKGA4510NTH	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S3007S	FDA UDI	Class II	Active
ET IV Fixture SA Regular No Mount	CET4R5010S	FDA UDI	Class II	Active
Et Smartfit Abutment	P-ETCMAMHC	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA6027SP	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR4521H	FDA UDI	Class I	Active
ET III Fixture SA Mini Pre-Mounted	AET3M3511S	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4730P	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6760NCWH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA6620TH	FDA UDI	Class II	Active
A-Oss®	AOSN025SV	FDA UDI	Class II	Unknown
Ek Fixture Transfer Impression Coping	EKTI4011	FDA UDI	Class I	Active
Ek Np-Cast Abutment	EKNA4510NTH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4771NCWH	FDA UDI	Class II	Active
Ek Fixture Lab Analog	EKTLA350	FDA UDI	Class I	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4010R18	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4752NCWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4632CWH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5015SNW	FDA UDI	Class II	Active
ET III Fixture SA Regular [ Implant Only]	ET3R4008S	FDA UDI	Class II	Active
Et Stud Abutment	ETSAM3540C	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4555MNW	FDA UDI	Class II	Active
ET Angled Abutment_A With EG Screw	ETAGA454MAW	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI7015SN	FDA UDI	Class I	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4515R18	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI4511MN	FDA UDI	Class I	Active
Et Ziocera Abutment	ETZCA455SNW	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICM4541HC	FDA UDI	Class I	Active
ET cover screw Mini	ETCSM3S	FDA UDI	Class II	Active
Et Freeform St Abutment Set	ETFAM4030NCWH	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4054MP	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