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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 33 of 65

Device	Model / Reference	Registries	Class	Status
Bite Impression Coping (Mini)	ETBICM4651	FDA UDI	Class I	Active
ET Rigid Abutment SET	ETRA5410CP	FDA UDI	Class II	Active
ET III Fixture SA Regular [ Implant Only]	ET3R5015S	FDA UDI	Class II	Active
ET Angled Abutment Set	ETAA4540NCWH	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIM4011NCA	FDA UDI	Class I	Active
EK III SA Fixture Pre-Mounted	AEK3S7006S	FDA UDI	Class II	Active
Et Rigid Impression Coping	ETRIC4507S	FDA UDI	Class I	Active
ET Convertible Temporary Cylinder	ETCTC400CWH	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA4671CWH	FDA UDI	Class II	Active
Em Sa Implant (denture)	EMD3015S40	FDA UDI	Class II	Active
ET III Fixture NH Regular No-Mounted	CET3R5007B	FDA UDI	Class II	Active
HM Implant Narrow Ridge	HMN3010R04	FDA UDI	Class II	Active
ET Multi Angled Abutment	ET17MAS4840CWH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4067MNW	FDA UDI	Class II	Active
Ek Fixture Transfer Impression Coping	EKTI7011	FDA UDI	Class I	Active
Smartfit Provisonal Denture	PROHYD	FDA UDI	Class I	Active
ET Pre-milled Abutment	ETPMA12CEMNW	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR4541H	FDA UDI	Class I	Active
ET Multi Angled Abutment	ET17MAS4820CWH	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICM4620HC	FDA UDI	Class I	Active
ET Multi Combination Cylinder	ETMC500CTH	FDA UDI	Class I	Active
EK III NH Fixture Pre-Mounted	AEK3S3013B	FDA UDI	Class II	Unknown
ET Transfer Abutment Set	ETTA4651NCWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA7430NCWH	FDA UDI	Class II	Active
ET Healing Abutment Regular, 4.3(D), 6.0(H)	ETHLA4006R	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6027SHW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4535MHW	FDA UDI	Class II	Active
ET Multi Angled Abutment	ET17MAM4820CWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5740NCWH	FDA UDI	Class II	Active
Et Rigid Impression Coping	ETRIC440SC	FDA UDI	Class I	Active
A-Oss®	AOSN010SV	FDA UDI	Class II	Unknown
HG II Fixture RBM Regular No Mount	CHG2S4015R	FDA UDI	Class II	Active
ET Fixture Lab Analog	ETTLA400C	FDA UDI	Class I	Active
ET III Fixture SA Regular Pre-Mounted	AET3R4010S	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR4441H	FDA UDI	Class I	Active
ET Angled Abutment_B With EG Screw	ETAGA434MBW	FDA UDI	Class II	Active
ET Temporary Abutment SET	ETTTA4030NCTH	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4641P	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4771CWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6710NCWH	FDA UDI	Class II	Active
Ek Fixture Transfer Impression Coping	EKTI4011N	FDA UDI	Class I	Active
Em Sa Implant (narrow Ridge)	EMN3013S40	FDA UDI	Class II	Active
Ek Angled Abutment_b	EKAA6040BTH	FDA UDI	Class II	Active
Et Rigid Lab Analog	ETRLA5007S	FDA UDI	Class I	Active
EK Hybrid Zirconia Abutment	EKHZ4064CNT	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4611CP	FDA UDI	Class II	Active
ET Healing Abutment	ETHLA4005R	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4630H	FDA UDI	Class I	Active
Ek Rigid Abutment	EKRA6610P	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5640TH	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