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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 63 of 65

Device	Model / Reference	Registries	Class	Status
ET Convertible Abutment	ETCAS4010CP	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6460NCWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA7650CWH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5420NTH	FDA UDI	Class II	Active
HG II Fixture RBM Regular No Mount	CHG2S4508R	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4650CP	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S6011S	FDA UDI	Class II	Active
Em Sa Implant (narrow Ridge)	EMN3015S40	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5460CWH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4640CP	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4741TH	FDA UDI	Class II	Active
ET Convertible Lab Analog	ETCLA400C	FDA UDI	Class I	Active
ET Link Abutment	ETCTBRNW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7064SHW	FDA UDI	Class II	Active
Bite Impression Coping	ETBICR5650	FDA UDI	Class I	Active
Et Rigid Protect Cap	ETRPC4004	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA7015SNW	FDA UDI	Class II	Active
Smartfit Final Hybrid Denture - 2	FNLHYD02	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICM4631HC	FDA UDI	Class I	Active
Martfit Bone Reduction Guide 8 Holes	ETSGBR08	FDA UDI	Class I	Active
ET IV NH Fixture No mount	CET4R5013B	FDA UDI	Class II	Active
ET III NH Ultra-Wide Fixture Pre-Mount	AET3R6010B	FDA UDI	Class II	Active
EK Freeform ST Abutment 6.0(3.0), Hex	EKFA6030TH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5620TH	FDA UDI	Class II	Active
ET III Fixture NH Regular [ Implant Only ]	ET3R4508B	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4421H	FDA UDI	Class I	Active
EK Healing Abutment	EKHA705	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S3011S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4045MHW	FDA UDI	Class II	Active
Esthetic-low Pick-Up Impression Coping	ETMSR100	FDA UDI	Class I	Active
ET Convertible Temporary Cylinder	ETCTC600CWH	FDA UDI	Class I	Active
EK Hybrid Zirconia Abutment	EKHZ4541OHT	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4642NTH	FDA UDI	Class II	Active
Em Sa Implant (denture)	EMD3010S20	FDA UDI	Class II	Active
HG II Ultra-Wide Fixture RBM Pre-Mounted	AHG2S7013R	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4641NTH	FDA UDI	Class II	Active
ET Convertible Temporary Cylinder	ETCTC600TCTH	FDA UDI	Class I	Active
Em Sa Implant (narrow Ridge)	EMN2513S40	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S4508B	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4721P	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICM4530HC	FDA UDI	Class I	Active
EK III NH Fixture No Mount	CEK3S6011B	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4741CP	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S7007B	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4712TH	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S3007B	FDA UDI	Class II	Unknown
ET Transfer Abutment Set	ETTA5450CWH	FDA UDI	Class II	Active
Hiossen Ti Abutment Screw	ETABSMT	FDA UDI	Class I	Active
ET3 D5.5 SA Pre-mounted	AET3R5506S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4545SNW	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