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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 64 of 65

Device	Model / Reference	Registries	Class	Status
ET Rigid Abutment	ETRGA6015SP	FDA UDI	Class II	Active
ET Link Abutment	ETCTBMNW	FDA UDI	Class II	Active
Em Sa Implant (denture)	EMD3011S40	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA7450NCWH	FDA UDI	Class II	Active
ET III Fixture NH Mini No-Mounted	CET3M3510B	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4622CWH	FDA UDI	Class II	Active
ET II Fixture SA Mini No-Mounted	CET2M3508S	FDA UDI	Class II	Active
HG II Ultra-Wide Fixture	CHG2S7013R	FDA UDI	Class II	Active
ET III Fixture SA Regular No Mount	CET3R5010S	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC5640	FDA UDI	Class I	Active
EK Healing Abutment	EKHA459	FDA UDI	Class II	Active
ET Quick Temporary Abutment	ETQTA455RHT	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA5024SP	FDA UDI	Class II	Active
Et Temporary Abutment	ETTPA403MHT	FDA UDI	Class II	Active
Multi Scan Body	ETMSBCC	FDA UDI	Class I	Active
ET Link Abutment	ETCTBRNCWH	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S6007S	FDA UDI	Class II	Unknown
Esthetic-low Polishing Protector	ETMPCR100	FDA UDI	Class I	Active
Et Rigid Retraction Cap	ETRRC540	FDA UDI	Class I	Active
ET Link Abutment	ETCTBMHW	FDA UDI	Class II	Active
Et Freeform St Abutment	ETFSA401MNW	FDA UDI	Class II	Active
ET EsthTSic-low Ti Cylinder Screw	ETMTS200C	FDA UDI	Class I	Active
EK III SA Fixture No Mount	CEK3S7006S	FDA UDI	Class II	Active
ET III Fixture SA Mini [ Implant Only]	ET3M3510S	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA6420NTH	FDA UDI	Class II	Active
ET IV NH Fixture No mount	CET4R4011B	FDA UDI	Class II	Active
HG II Ultra-Wide Fixture RBM Pre-Mounted	AHG2S7007R	FDA UDI	Class II	Active
HG III Fixture RBM Regular No Mount	CHG3S4013R	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7034SNW	FDA UDI	Class II	Active
HG II Ultra-Wide Fixture	CHG2S6013R	FDA UDI	Class II	Active
ET Multi Abutment	ETMA5030CP	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S7010B	FDA UDI	Class II	Unknown
ET Transfer Abutment Set	ETTA6470NCWH	FDA UDI	Class II	Active
Et Rigid Impression Coping	ETRIC560SC	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA5410TH	FDA UDI	Class II	Active
HG II Fixture RBM Mini No Mount	CHG2M3511R	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S7013S	FDA UDI	Class II	Unknown
Et Pick-Up Guide Pin	ETPGPM150C	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA5035SHW	FDA UDI	Class II	Active
Et Stud Abutment Set	ETSAO352M	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4565SNW	FDA UDI	Class II	Active
Et Rigid Impression Coping	ETRIC4005S	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIS4015AC	FDA UDI	Class I	Active
Et Ii Bio-Sa Fixture System	K112532	FDA 510(k)	Class II	Active
Hg Iii Fixture System	K093352	FDA 510(k)	Class II	Active
ET Hybrid Abutment	K170421	FDA 510(k)	Class II	Active
ET Abutment System	K222636	FDA 510(k)	Class II	Active
EM Provisional	K191751	FDA 510(k)	Class II	Active
EK D3.3 and Ultra Wide Implants	K240232	FDA 510(k)	Class II	Active
Ek Multi Angled 30 Abutment	K251427	FDA 510(k)	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