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 35 of 65

Device	Model / Reference	Registries	Class	Status
EK III SA Fixture Pre-Mounted	AEK3S7007S	FDA UDI	Class II	Unknown
HG III Fixture RBM Regular Pre-Mounted	AHG3S4007R	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICM4640H	FDA UDI	Class I	Active
EK Hybrid Zirconia Abutment	EKHZ4044ONT	FDA UDI	Class II	Active
Metal sleeve narrow	HOGSCN70S	FDA UDI	Class I	Active
ET IV Fixture SA Regular Pre-Mounted	AET4R4513S	FDA UDI	Class II	Active
EM Provisional	EMT18154	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA5730CP	FDA UDI	Class II	Active
Et Rigid Impression Coping	ETRIC4007S	FDA UDI	Class I	Active
Bite Impression Coping	ETBICR4621	FDA UDI	Class I	Active
ET IV NH Fixture Pre-Mounted	AET4R4511B	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S3510B	FDA UDI	Class II	Active
ET FIXTURE PICK-UP IMPRESSION COPING Mini Hex	ETFTI4020MH	FDA UDI	Class I	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4511R18	FDA UDI	Class II	Active
Et Freeform St Abutment	ETFSA403MNW	FDA UDI	Class II	Active
EK Scan body (Long)	EKSBOS	FDA UDI	Class I	Active
EK Pre-milled Abutment	EKPMA14ARNT	FDA UDI	Class II	Active
EM Provisional	EMT25134	FDA UDI	Class II	Active
ET Angled Abutment(N) With EG Screw	ETAGA554SNW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7014SNW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA7450CWH	FDA UDI	Class II	Active
Ek Fixture Transfer Impression Coping	EKTI5014N	FDA UDI	Class I	Active
ET Multi Digital Lab Analog	ETMDLA	FDA UDI	Class I	Active
HG III Fixture RBM Mini No Mount	CHG3M3508R	FDA UDI	Class II	Active
ET Multi Ti Base Set	ETTSMTB0605GCTH	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICR5430HC	FDA UDI	Class I	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R5011R28	FDA UDI	Class II	Active
ET III Fixture NH Regular [ Implant Only ]	ET3R4513B	FDA UDI	Class II	Active
HG III Fixture RBM Regular No Mount	CHG3S5007R	FDA UDI	Class II	Active
ET III Fixture SA Mini Pre-Mounted	AET3M3510S	FDA UDI	Class II	Active
Et O-Ring Lab Analog	ETOALC	FDA UDI	Class I	Active
ET Angled Abutment Set	ETAA4540MACWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5420CWH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4620CP	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR5620H	FDA UDI	Class I	Active
EK III SA Fixture No Mount	CEK3S3010S	FDA UDI	Class II	Unknown
Et Rigid Lab Analog	ETRLA6007S	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA5017SHW	FDA UDI	Class II	Active
ET III Fixture NH Mini [ Implant Only ]	ET3M3510B	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S4007B	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5037SNW	FDA UDI	Class II	Active
Et Pick-Up Guide Pin	ETPGPM100C	FDA UDI	Class I	Active
EK III SA Fixture No Mount	CEK3S3511S	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETTIS7014NC	FDA UDI	Class I	Active
Et Ziocera Abutment	ETZCA555SNW	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA6730NTH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6720NCWH	FDA UDI	Class II	Active
EK Pre-milled Abutment	EKPMA10MXNT	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4062CHT	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R5015R28	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