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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 58 of 65

Device	Model / Reference	Registries	Class	Status
EK III NH Fixture Pre-Mounted	AEK3S7008B	FDA UDI	Class II	Active
Et Rigid Impression Coping	ETRIC760SC	FDA UDI	Class I	Active
Smartfit Final Hybrid Denture - 7	FNLHYD07	FDA UDI	Class I	Active
ET II Fixture SA Regular Pre-Mounted	AET2R5007S	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4650	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA5650TH	FDA UDI	Class II	Active
HG III Ultra-Wide Fixture RBM Pre-Mounted	AHG3S7007R	FDA UDI	Class II	Active
ET Convertible Temporary Cylinder Set	ETCTC600TTHC	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA4711NTH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA7450TH	FDA UDI	Class II	Active
ET IV Fixture SA Regular No Mount	CET4R4007S	FDA UDI	Class II	Active
Bite Impression Coping (Mini)	ETBICM4641	FDA UDI	Class I	Active
EK III SA Fixture Pre-Mounted	AEK3S4011S	FDA UDI	Class II	Active
ET Multi Angled Abutment	ETMA217MHW	FDA UDI	Class II	Active
Bite Impression Coping	ETBICR4421	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA4517MNW	FDA UDI	Class II	Active
Et Pick-Up Guide Pin	ETFPG10ML	FDA UDI	Class I	Active
ET III Fixture NH Regular Pre-Mounted	AET3R4515B	FDA UDI	Class II	Active
ET III NH Ultra-Wide Fixture Pre-Mount	AET3R7010B	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S7008B	FDA UDI	Class II	Unknown
ET Convertible Combination Cylinder	ETCC5070CWH	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA7440TH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4752TH	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA6410P	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA6650TH	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4555MP	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S7008B	FDA UDI	Class II	Unknown
Bite Impression Coping (Mini)	ETBICM4420	FDA UDI	Class I	Active
ET Multi Abutment	ETMTA504R	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4055MNW	FDA UDI	Class II	Active
ET Multi Angled Abutment Screw	ETMABSSC	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA4662CWH	FDA UDI	Class II	Active
Smartfit Ek Mua Sh Ek Mua Standaed Hex	EKCMAMASH	FDA UDI	Class I	Active
Ek Rigid Abutment	EKRA5420P	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI7015SH	FDA UDI	Class I	Active
EK Healing Abutment	EKHA805	FDA UDI	Class II	Active
Ek Fixture Transfer Impression Coping	EKTI4014	FDA UDI	Class I	Active
Et Temporary Abutment	ETTPA403MNT	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR4621H	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICM4431HC	FDA UDI	Class I	Active
EK III SA Fixture Pre-Mounted	AEK3S4511S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6017SNW	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4554MP	FDA UDI	Class II	Active
ET IV Fixture SA Ultra-Wide No Mount	CET4R6013S	FDA UDI	Class II	Active
ET III SA Ultra-Wide Fixture Pre-Mounted	AET3R7010S	FDA UDI	Class II	Active
HG II Fixture RBM Regular No Mount	CHG2S4507R	FDA UDI	Class II	Active
ET Convertible Angled Cylinder	ET17CC4080NCWH	FDA UDI	Class I	Active
ET III SA Ultra-Wide Fixture No Mount	CET3R7008S	FDA UDI	Class II	Active
Et Rigid Lab Analog	ETRLA461C	FDA UDI	Class I	Active
ET III Fixture SA Regular No Mount	CET3R5007S	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