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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 56 of 65

Device	Model / Reference	Registries	Class	Status
ET Angled Abutment	ETAA4020MBC	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5620NTH	FDA UDI	Class II	Active
Et Rigid Protect Cap	ETRPC4507	FDA UDI	Class I	Active
ET Rigid Abutment SET	ETRAS4421CP	FDA UDI	Class II	Active
ET III Fixture SA Regular Pre-Mounted	AET3R4513S	FDA UDI	Class II	Active
Ek Stud Abutment Small	EKST3510	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4642NCWH	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S6013S	FDA UDI	Class II	Active
Ek Bite Index	EKBI5506S	FDA UDI	Class I	Active
Ek Rigid Abutment	EKRA7630P	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4631	FDA UDI	Class I	Active
Et Bite Index	ETBIM4510SC	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA4612NTH	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4431P	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5760CWH	FDA UDI	Class II	Active
Et Ziocera Abutment	ETZCA655SNW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5620CWH	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETTIS7011NC	FDA UDI	Class I	Active
ET Pre-milled Abutment	ETPMA10HUMNW	FDA UDI	Class II	Active
HG III Fixture RBM Regular No Mount	CHG3S4011R	FDA UDI	Class II	Active
A-Oss®	AOSN050LV	FDA UDI	Class II	Unknown
ET Transfer Abutment Set	ETTA4672CWH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA7610NTH	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA6440P	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7045SNW	FDA UDI	Class II	Active
HG III Fixture RBM Regular Pre-Mounted	AHG3S4511R	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA5710P	FDA UDI	Class II	Active
ET III Fixture NH Regular Pre-Mounted	AET3R5006B	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4015MNW	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S4508S	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA5055SP	FDA UDI	Class II	Active
ETIII SA (Ø3.2mm) Pre-mounted	AET3M3008S	FDA UDI	Class II	Active
Et Freeform St Abutment	ETFSAS501SHW	FDA UDI	Class II	Active
ET III Fixture NH Mini Pre-Mounted	AET3M3513B	FDA UDI	Class II	Active
ET III SA Ultra-Wide Fixture Pre-Mounted	AET3R6011S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4711NCWH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7055SNW	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4508R18	FDA UDI	Class II	Active
Et Stud Abutment	ETSAM3520C	FDA UDI	Class II	Active
Et Stud Abutment	ETSAO356S	FDA UDI	Class II	Active
ET III Fixture SA Regular Pre-Mounted	AET3R5010S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5025SNW	FDA UDI	Class II	Active
ET III Fixture NH Regular Pre-Mounted	AET3R5007B	FDA UDI	Class II	Active
ET Ebony Gold Screw	ETABSMC	FDA UDI	Class I	Active
ET Healing Abutment	ETHLA7007R	FDA UDI	Class II	Active
ET Abutment Laboratory Screw	ETABSMWC	FDA UDI	Class I	Active
EK cover screw Short	EKCS30S	FDA UDI	Class II	Active
EK Pre-milled Abutment	EKPMA14MXHT	FDA UDI	Class II	Active
Ek Stud Abutment Small	EKST3560	FDA UDI	Class II	Active
Ek Fixture Transfer Impression Coping	EKTI7011N	FDA UDI	Class I	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