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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 16 of 65

Device	Model / Reference	Registries	Class	Status
Ek Rigid Abutment	EKRA5740P	FDA UDI	Class II	Active
ET IV NH Fixture No mount	CET4R4010B	FDA UDI	Class II	Active
Esthetic-low Temporary Abutment	ETMTR200TH	FDA UDI	Class I	Active
ET Convertible Pick-up Impression Coping	ETPIC600C	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA4557MNW	FDA UDI	Class II	Active
ET III Fixture SA Regular Pre-Mounted	AET3R4008S	FDA UDI	Class II	Active
ET Angled Abutment	ETAA5020AC	FDA UDI	Class II	Active
Smartfit Try In Hybrid Denture - 8	TRYHYD08	FDA UDI	Class I	Active
ET IV Fixture SA Regular Pre-Mounted	AET4R4511S	FDA UDI	Class II	Active
ET O-ring Set (Regular)	ETOAON02S	FDA UDI	Class I	Active
ET Abutment Laboratory Screw	ETABSST	FDA UDI	Class I	Active
ET3 D5.5 NH No mount	CET3R5507B	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4577SNW	FDA UDI	Class II	Active
Ek Temporary Abutment	EKTTA4530NTH	FDA UDI	Class II	Active
EK Healing Abutment	EKHA607	FDA UDI	Class II	Active
Et Stud Abutment	ETSA3560C	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICM4651HC	FDA UDI	Class I	Active
Esthetic-low Polishing Protector	ETMPCW100	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA4632NCWH	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S5513B	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR5660H	FDA UDI	Class I	Active
EK III SA Fixture No Mount	CEK3S5508S	FDA UDI	Class II	Active
ET Angled Abutment Set	ETAA5040BCWH	FDA UDI	Class II	Active
Et Rigid Protect Cap	ETRPC460C	FDA UDI	Class I	Active
ET III Fixture NH Mini D3.2 No Mount	CET3M3008B	FDA UDI	Class II	Active
ET Healing Abutment	ETHLA7005R	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S3508B	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICM4521HC	FDA UDI	Class I	Active
ET Angled Abutment Set	ETAA4520MBCWH	FDA UDI	Class II	Active
Et Freeform St Abutment	ETFSA501SHW	FDA UDI	Class II	Active
ET IV NH Ultra-Wide Fixture No mount	CET4R7008B	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S6006S	FDA UDI	Class II	Active
Esthetic-low Pick-Up Impression Coping	ETMSW200	FDA UDI	Class I	Active
EK III SA Fixture Pre-Mounted	AEK3S6011S	FDA UDI	Class II	Active
EK Pre-milled Abutment	EKPMA14ANHT	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR5620HC	FDA UDI	Class I	Active
ET III Fixture SA Mini No Mount	CET3M3515S	FDA UDI	Class II	Active
ET II Fixture SA Regular Pre-Mounted	AET2R5008S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6045SNW	FDA UDI	Class II	Active
ET IV Fixture SA Ultra-Wide No Mount	CET4R7008S	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4721CP	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4564CNT	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4631NTH	FDA UDI	Class II	Active
Smartfit Bone Reduction Guide 4 Holes	ETSGBR04	FDA UDI	Class I	Active
ET III Fixture NH Regular Pre-Mounted	AET3R5015B	FDA UDI	Class II	Active
Ek Stud Abutment Normal	EKSA3540	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4544CNT	FDA UDI	Class II	Active
ET Digital Lab Analog Mini	ETDLA350	FDA UDI	Class I	Active
ET Convertible Transfer Imp. Coping	ETTIC480C	FDA UDI	Class I	Active
ET Multi Ti Base Set	ETTSMTB0405GCTH	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