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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 8 of 65

Device	Model / Reference	Registries	Class	Status
ET Rigid Abutment	ETRGA4525SP	FDA UDI	Class II	Active
ET III SA Ultra-Wide Fixture No Mount	CET3R6010S	FDA UDI	Class II	Active
Et O-Ring Retainer Cap	ETOARCCC	FDA UDI	Class I	Active
Et Stud Abutment Set	ETSAO355M	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4527SP	FDA UDI	Class II	Active
ET Multi Angled Abutment	ETMA217SHW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4612CWH	FDA UDI	Class II	Active
ET Convertible Transfer Imp. Coping	ETTIC400C	FDA UDI	Class I	Active
ET Bite Impression Coping Hex	ETBICM4660H	FDA UDI	Class I	Active
ET FIXTURE PICK-UP IMPRESSION COPING Mini Hex	ETFPI5020MH	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA4752CWH	FDA UDI	Class II	Active
Et Stud Abutment	ETSAO351S	FDA UDI	Class II	Active
HG III Fixture RBM Regular No Mount	CHG3S5011R	FDA UDI	Class II	Active
ET Healing Abutment	ETHLA4007R	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5410NTH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4741CP	FDA UDI	Class II	Active
Et Freeform St Abutment Set	ETFA5030CWH	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4720P	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4513R18	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4750CP	FDA UDI	Class II	Active
Bite Impression Coping	ETBICR5450	FDA UDI	Class I	Active
EK III NH Fixture Pre-Mounted	AEK3S7010B	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S7010S	FDA UDI	Class II	Unknown
Et Rigid Protect Cap	ETRPC5004S	FDA UDI	Class I	Active
Et Stud Abutment	ETSAM3510C	FDA UDI	Class II	Active
Et Rigid Protect Cap	ETRPC440C	FDA UDI	Class I	Active
ET III Fixture NH Mini D3.2 Pre-Mounted	AET3M3011B	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5055SNW	FDA UDI	Class II	Active
Ek Angled Abutment_b	EKAA5040BTH	FDA UDI	Class II	Active
HG II Fixture Regular RBM Pre-Mounted	AHG2S5008R	FDA UDI	Class II	Active
EK Freeform ST Abutment 7.0(3.0), Hex	EKFA7030TH	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10UKMHW	FDA UDI	Class II	Active
Ek Healing Abutment	EKHA404	FDA UDI	Class II	Active
Et Freeform St Abutment Set	ETFA6030NCWH	FDA UDI	Class II	Active
ET SmartFit Abutment	ETCMAMH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4651TH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA7410NCWH	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI5020SN	FDA UDI	Class I	Active
HySil Mono	ESS50M	FDA UDI	Class II	Active
HM Implant Narrow Ridge	HMN2510R04	FDA UDI	Class II	Active
ET III Fixture SA Regulsr Pre-Mounted	AET3R5006S	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S3007S	FDA UDI	Class II	Unknown
ET Temporary Abutment SET	ETTTA4030CTH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5430CWH	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4544MP	FDA UDI	Class II	Active
ETIII SA (Ø3.2mm) [ Implant Only ]	ET3M3008S	FDA UDI	Class II	Active
ET cover screw Mini (D) 3.0, Middle	ETCS30M	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S7008S	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4631H	FDA UDI	Class I	Active
ET Rigid Abutment SET	ETRA4651CP	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