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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 37 of 65

Device	Model / Reference	Registries	Class	Status
Et Fixture Pick-Up Impression Coping	ETPIM4011NAC	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA7025SNW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5620NCWH	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI4011MH	FDA UDI	Class I	Active
Smartfit Try In Hybrid Denture - 5	TRYHYD05	FDA UDI	Class I	Active
ET Multi Abutment	ETMTA502R	FDA UDI	Class II	Active
Smartfit Et Mua Mh Et Mua Mini Hex	ETCMAMAMH	FDA UDI	Class I	Active
ET Convertible GoldCast Cylinder	ETGC500CWH	FDA UDI	Class I	Active
ET Convertible Abutment	ETCA6030CP	FDA UDI	Class II	Active
ET Temporary Abutment SET	ETTTA4010CTH	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI4514MN	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA4037MHW	FDA UDI	Class II	Active
ET III Fixture SA Regular Pre-Mounted	AET3R5008S	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICM4550H	FDA UDI	Class I	Active
ET IV Fixture SA Regular Pre-Mounted	AET4R4008S	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10ZKMNW	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4631HC	FDA UDI	Class I	Active
ET III Fixture NH Regular Pre-Mounted	AET3R4015B	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4515MHW	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4527MP	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI4515SH	FDA UDI	Class I	Active
Et Rigid Retraction Cap	ETRRC560C	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA4055SP	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4547MHW	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5720TH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5650NTH	FDA UDI	Class II	Active
Ek Angled Abutment(n)	EKAA5020NTH	FDA UDI	Class II	Active
Bite Impression Coping (Mini)	EKBIC4641	FDA UDI	Class I	Active
Ek Angled Abutment_a	EKAA4020ATH	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S6008B	FDA UDI	Class II	Active
ET SmartFit Abutment	ETCMASN	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S6010B	FDA UDI	Class II	Unknown
ET Bite Impression Coping Hex	ETBICM4630H	FDA UDI	Class I	Active
ET Rigid Abutment SET	ETRAS4731CP	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5470NCWH	FDA UDI	Class II	Active
A-graft®[Bone grafting material, Animal source]	HAS200LV	FDA UDI	Class II	Active
ET III Fixture NH Regular No-Mounted	CET3R4011B	FDA UDI	Class II	Active
Ek Angled Abutment_b	EKAA4540BTH	FDA UDI	Class II	Active
HG II Ultra-Wide Fixture	CHG2S7007R	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6410CWH	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC5420	FDA UDI	Class I	Active
Esthetic-low Pick-Up Impression Coping Guide Pin	ETGP150	FDA UDI	Class I	Active
Et Rigid Protect Cap	ETRPC560C	FDA UDI	Class I	Active
Et Rigid Protect Cap	ETRPC4005	FDA UDI	Class I	Active
ET Angled Abutment Set	ETAA5040ACWH	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R5013R28	FDA UDI	Class II	Active
EK Healing Abutment	EKHA605	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4075MNW	FDA UDI	Class II	Active
HG II Fixture Regular RBM Pre-Mounted	AHG2S4013R	FDA UDI	Class II	Active
Et Smartfit Abutment	P-ETCMAMNC	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