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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 46 of 65

Device	Model / Reference	Registries	Class	Status
ET III Fixture SA Regular Pre-Mounted	AET3R4011S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA7620CWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6660CWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4611NCWH	FDA UDI	Class II	Active
ET Hybrid Abutment	ETCMAMNZS	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S3010B	FDA UDI	Class II	Active
SMARTFIT FINAL HYBRID DENTURE -No Hole	FNLHYD00	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S7006B	FDA UDI	Class II	Active
Ek Bite Index	EKBI4510S	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIM4015NAC	FDA UDI	Class I	Active
HG II Fixture RBM Regular No Mount	CHG2S4011R	FDA UDI	Class II	Active
ET III Fixture SA Regular Pre-Mounted	AET3R4510S	FDA UDI	Class II	Active
HG III Fixture RBM Regular No Mount	CHG3S4510R	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S3010B	FDA UDI	Class II	Active
Esthetic-low Lab Analog	ETMERW300	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETFPI5015SH	FDA UDI	Class I	Active
ET II Fixture SA Regular No-Mounted	CET2R4507S	FDA UDI	Class II	Active
ET III Fixture NH Mini No-Mounted	CET3M3508B	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4507R18	FDA UDI	Class II	Active
ET Esthetic-low Plastic Cylinder	ETMEPR100CTH	FDA UDI	Class I	Active
ET Convertible Pick-up Guide Pin	ETCGP480LC	FDA UDI	Class I	Active
EK cover screw Long	EKCS30L	FDA UDI	Class II	Active
ET O-Ring Retainer Cap Set (Regular)	ETRCS01	FDA UDI	Class I	Active
HG II Ultra-Wide Fixture	CHG2S6007R	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4730CP	FDA UDI	Class II	Active
HG II Fixture RBM Regular No Mount	CHG2S5010R	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4025MNW	FDA UDI	Class II	Active
Screw-ZioCera ABT	ETASR	FDA UDI	Class I	Active
Et Rigid Retraction Cap	ETRRC640	FDA UDI	Class I	Active
Ek Rigid Abutment	EKRA4630P	FDA UDI	Class II	Active
ET III Fixture NH Regular [ Implant Only ]	ET3R4510B	FDA UDI	Class II	Active
ET III Fixture NH Regular [ Implant Only ]	ET3R4511B	FDA UDI	Class II	Active
Bite Impression Coping (Mini)	ETBICM4620	FDA UDI	Class I	Active
HM Implant Denture	HMD3015R02	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIM4515NAC	FDA UDI	Class I	Active
Et Rigid Retraction Cap	ETRRC540C	FDA UDI	Class I	Active
ET III SA Ultra-Wide Fixture No Mount	CET3R7006S	FDA UDI	Class II	Active
ET Convertible Combination Cylinder	ETCC6070CWH	FDA UDI	Class I	Active
EK Bite Impression Coping	EKBIC4420H	FDA UDI	Class I	Active
ET Pre-milled Abutment	ETPMA14ANMHW	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA5035SP	FDA UDI	Class II	Active
Et Temporary Abutment	ETTPA451SHT	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA7410TH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA7420TH	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4514SP	FDA UDI	Class II	Active
ET Multi Ti Base	ETMTB0405	FDA UDI	Class II	Active
Ek Fixture Transfer Impression Coping	EKTI5011N	FDA UDI	Class I	Active
ET IV NH Fixture No mount	CET4R4513B	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S4508B	FDA UDI	Class II	Active
Et Bite Index	ETBIM4506S	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