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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 21 of 65

Device	Model / Reference	Registries	Class	Status
ET III Fixture NH Regular No-Mounted	CET3R5015B	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETTIM4014NC	FDA UDI	Class I	Active
ET Pre-milled Abutment	ETPMA14ARRHW	FDA UDI	Class II	Active
Et Rigid Lab Analog	ETRLA440C	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA6047SP	FDA UDI	Class II	Active
ET Convertible Pick-up Impression Coping	ETPIC480C	FDA UDI	Class I	Active
ET Multi Angled Abutment Screw	ETMABSMC	FDA UDI	Class I	Active
EK Hybrid Zirconia Abutment	EKHZ4543CNT	FDA UDI	Class II	Active
Et Freeform St Abutment	ETFSA401MHW	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4015R18	FDA UDI	Class II	Active
ET III NH Ultra-Wide Fixture Pre-Mount	AET3R7013B	FDA UDI	Class II	Active
ET III SA Ultra-Wide Fixture Pre-Mounted	AET3R6007S	FDA UDI	Class II	Active
EK cover screw Short	EKCS40S	FDA UDI	Class II	Active
EK Healing Abutment	EKHA405	FDA UDI	Class II	Active
Hiossen	AET3M3011S	FDA UDI	Class II	Active
Et Freeform St Abutment	ETFSA401SNW	FDA UDI	Class II	Active
Et Rigid Protect Cap	ETRPC570C	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIM4511AC	FDA UDI	Class I	Active
EK III SA Fixture Pre-Mounted	AEK3S3008S	FDA UDI	Class II	Active
ET II Fixture SA Mini No-Mounted	CET2M3513S	FDA UDI	Class II	Active
HG III Fixture RBM Regular No Mount	CHG3S4008R	FDA UDI	Class II	Active
ET cover screw Regular	ETCSRS	FDA UDI	Class II	Active
Et Temporary Abutment	ETTPA451SNT	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S6007S	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S6006S	FDA UDI	Class II	Unknown
Esthetic-low Lab Analog	ETMERR300	FDA UDI	Class I	Active
HG II Ultra-Wide Fixture	CHG2S6011R	FDA UDI	Class II	Active
ET III SA Ultra-Wide Fixture Pre-Mounted	AET3R6013S	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S5508B	FDA UDI	Class II	Active
ETIII SA (Ø3.2mm) [ Implant Only ]	ET3M3011S	FDA UDI	Class II	Active
Ek Fixture Pick-Up Impression Coping	EKPI4011N	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA6710NTH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6630NCWH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA5450CP	FDA UDI	Class II	Active
ET III Fixture NH Mini Pre-Mounted	AET3M3508B	FDA UDI	Class II	Active
ET Esthetic-low Temporary Cylinder Set	ETMTR200CTH	FDA UDI	Class I	Active
EK III NH Fixture Pre-Mounted	AEK3S5508B	FDA UDI	Class II	Active
ET Convertible GoldCast Cylinder	ETGC400NCWH	FDA UDI	Class I	Active
ET Angled Abutment Set	ETAA4020MNCWH	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S7007S	FDA UDI	Class II	Unknown
EK Hybrid Zirconia Abutment	EKHZ4544CHT	FDA UDI	Class II	Active
ET Digital Lab Analog Screw Bulk	ETDLASB	FDA UDI	Class I	Active
Et Fixture Transfer Impression Coping	ETFTI4014SH	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA4537SNW	FDA UDI	Class II	Active
ET Multi Angled Abutment	ETMA530MHW	FDA UDI	Class II	Active
HG III Fixture RBM Mini Pre-Mounted	AHG3M3513R	FDA UDI	Class II	Active
ET Healing Abutment	ETHLA4004R	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S4507B	FDA UDI	Class II	Active
ET III Fixture BA Mini Pre-Mounted	AET3M3511B	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5730NCWH	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