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 41 of 65

Device	Model / Reference	Registries	Class	Status
Metal sleeve Regular	HOGSCR35S	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIS6011CA	FDA UDI	Class I	Active
Metal sleeve wide	HOGSCW70S	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETFPI4015SN	FDA UDI	Class I	Active
EK Healing Abutment	EKHA456	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4531HC	FDA UDI	Class I	Active
ET III Fixture SA Mini No Mount	CET3M3510S	FDA UDI	Class II	Active
ET O-Ring Retainer Cap	ETOARC02	FDA UDI	Class I	Active
Ek Temporary Abutment	EKTTA4030TH	FDA UDI	Class II	Active
Ek Fixture Pick-Up Impression Coping	EKPI7016	FDA UDI	Class I	Active
HM Implant Narrow Ridge	HMN2515R04	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10MXMHW	FDA UDI	Class II	Active
Et Freeform St Abutment Set	ETFA5015NCWH	FDA UDI	Class II	Active
ET III Fixture NH Regular Pre-Mounted	AET3R5013B	FDA UDI	Class II	Active
HG II Fixture RBM Regular No Mount	CHG2S5015R	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6440NCWH	FDA UDI	Class II	Active
HG II Fixture Regular RBM Pre-Mounted	AHG2S4515R	FDA UDI	Class II	Active
Ek Angled Abutment(n)	EKAA5040NTH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4440CP	FDA UDI	Class II	Active
ET III Fixture BA Regular Pre-Mounted	AET3R4515B	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4620H	FDA UDI	Class I	Active
EK Bite Impression Coping	EKBIC4441H	FDA UDI	Class I	Active
EK III NH Fixture No Mount	CEK3S6006B	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4711P	FDA UDI	Class II	Active
Ek Fixture Transfer Impression Coping	EKTI7014N	FDA UDI	Class I	Active
ET Rigid Abutment SET	ETRAS4720CP	FDA UDI	Class II	Active
Et Freeform St Abutment	ETFSAS503SNW	FDA UDI	Class II	Active
HG II Ultra-Wide Fixture RBM Pre-Mounted	AHG2S7008R	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5035SNW	FDA UDI	Class II	Active
ET Convertible Polishing Protector	ETCPC500C	FDA UDI	Class I	Active
ET IV NH Fixture No mount	CET4R4013B	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4731NCWH	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI5014SH	FDA UDI	Class I	Active
ET Angled Abutment Set	ETAA4540MNCWH	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI6011SH	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICM4420HC	FDA UDI	Class I	Active
Et Stud Abutment Set	ETSAO356M	FDA UDI	Class II	Active
Ek Multi Abutment	EKMA5040P	FDA UDI	Class II	Active
ET III Fixture NH Regular No-Mounted	CET3R4010B	FDA UDI	Class II	Active
EK Onefit Abutment(Gold)	EKCMANCT	FDA UDI	Class II	Active
Et Freeform St Abutment	ETFSA703SNW	FDA UDI	Class II	Active
ET Gold Cast Abutment SET	ETGA4030BCWH	FDA UDI	Class II	Active
ET3 D5.5 NH Pre-mounted	AET3R5506B	FDA UDI	Class II	Active
Ek Goldcast Abutment	EKGA4510TH	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10MXRNW	FDA UDI	Class II	Active
Esthetic-low Healing Cap	ETMHCW100	FDA UDI	Class I	Active
ET Esthetic-low Pick-Up Impression Coping Guide Pin	ETGP170C	FDA UDI	Class I	Active
ET Bite Impression Coping Hex	ETBICM4520H	FDA UDI	Class I	Active
ET Convertible Angled Cylinder	ETAC6080TCWH	FDA UDI	Class I	Active
EK III NH Fixture Pre-Mounted	AEK3S6006B	FDA UDI	Class II	Unknown

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