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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: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3007135442
DUNS Number: —

Catalogue (3217)

Page 15 of 65

Device	Model / Reference	Registries	Class	Status
Et O-Ring	ETOAON01SC	FDA UDI	Class I	Active
ET Healing Abutment	ETHLA6005R	FDA UDI	Class II	Active
Em Sa Implant (denture)	EMD2010S40	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S7011S	FDA UDI	Class II	Unknown
ET Bite Impression Coping	ETBICR4451HC	FDA UDI	Class I	Active
ET III Fixture SA Regular No Mount	CET3R4508S	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA6730CP	FDA UDI	Class II	Active
Smartfit Bone Reduction Guide 1 Hole	ETSGBR01	FDA UDI	Class I	Active
Et Freeform St Abutment Set	ETFA7030NCWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4631NCWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4641CWH	FDA UDI	Class II	Active
ET Healing Abutment Regular, 4.8(D), 6.0(H)	ETHLA4506R	FDA UDI	Class II	Active
ET IV Fixture SA Ultra-Wide No Mount	CET4R6007S	FDA UDI	Class II	Active
Esthetic-low Temporary Abutment	ETNMTW200TH	FDA UDI	Class I	Active
3d Lab Analog	ETFLAM3D	FDA UDI	Class I	Active
HG III Fixture RBM Regular No Mount	CHG3S5013R	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA7640CWH	FDA UDI	Class II	Active
Et Rigid Impression Coping	ETRIC460SC	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA4742NCWH	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4651P	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4630CP	FDA UDI	Class II	Active
Ek Temporary Abutment	EKTTA4010NTH	FDA UDI	Class II	Active
Ek Bite Index	EKBI5512S	FDA UDI	Class I	Active
ET Angled Abutment Set	ETAA4540ACWH	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC5420H	FDA UDI	Class I	Active
Ek Angled Abutment_b	EKAA4020BTH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5430NCWH	FDA UDI	Class II	Active
ET III Fixture NH Regular Pre-Mounted	AET3R4511B	FDA UDI	Class II	Active
ET Convertible Abutment	ETCA4020CP	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4672NCWH	FDA UDI	Class II	Active
ET II Fixture SA Regular No-Mounted	CET2R5007S	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICM4430HC	FDA UDI	Class I	Active
Et Stud Abutment	ETSAO356M	FDA UDI	Class II	Active
ET IV NH Ultra-Wide Fixture No mount	CET4R6013B	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S5508S	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4044CHT	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS4515NCA	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIM4511NAC	FDA UDI	Class I	Active
Ek Rigid Abutment	EKRA5440P	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6075SHW	FDA UDI	Class II	Active
Ek Fixture Transfer Impression Coping	EKTI7014	FDA UDI	Class I	Active
EK III SA Fixture Pre-Mounted	AEK3S4507S	FDA UDI	Class II	Active
Em Sa Implant (denture)	EMD2011S40	FDA UDI	Class II	Active
ET cover screw Regular, Middle	ETCS40M-G	FDA UDI	Class II	Active
Et Rigid Lab Analog	ETRLA7005S	FDA UDI	Class I	Active
ET III Fixture SA Regular No Mount	CET3R4010S	FDA UDI	Class II	Active
ET Convertible Angled Cylinder	ET17CC4080CWH	FDA UDI	Class I	Active
HG III Fixture RBM Regular Pre-Mounted	AHG3S5008R	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4440H	FDA UDI	Class I	Active
EK III NH Fixture No Mount	CEK3S6013B	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