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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 30 of 65

Device	Model / Reference	Registries	Class	Status
EK Transfer Abutment	EKTA6430TH	FDA UDI	Class II	Active
Et Np-Cast Abutment	ETNCA403MHW	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4554SP	FDA UDI	Class II	Active
ET Bite Impression Coping Hex ET Bite Impression Coping Hex	ETBICM4650H	FDA UDI	Class I	Active
Ek Rigid Abutment	EKRA7610P	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4055MHW	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI7011SN	FDA UDI	Class I	Active
ET III SA Ultra-Wide Fixture No Mount	CET3R6006S	FDA UDI	Class II	Active
Smartfit Final Hybrid Denture - 8	FNLHYD08	FDA UDI	Class I	Active
A-Oss®	AOSN100LV	FDA UDI	Class II	Unknown
HG III Fixture RBM Regular No Mount	CHG3S4007R	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5710NTH	FDA UDI	Class II	Active
HG II Fixture Regular RBM Pre-Mounted	AHG2S4008R	FDA UDI	Class II	Active
Et Freeform St Abutment Set	ETFAS5015NCWH	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4513R28	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S6013B	FDA UDI	Class II	Unknown
EK Healing Abutment	EKHA604	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4430	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA4742TH	FDA UDI	Class II	Active
ET IV NH Ultra-Wide Fixture Pre-Mounted	AET4R6013B	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4731TH	FDA UDI	Class II	Active
Smartfit Bone Reduction Guide 3 Holes	ETSGBR03	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA4515MP	FDA UDI	Class II	Active
Et Rigid Retraction Cap	ETRRC460C	FDA UDI	Class I	Active
ET III Fixture NH Mini [ Implant Only ]	ET3M3508B	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR5530HC	FDA UDI	Class I	Active
ET Esthetic-low Pick-Up Impression Coping Guide Pin	ETGP150C	FDA UDI	Class I	Active
Ek Fixture Pick-Up Impression Coping	EKPI5011N	FDA UDI	Class I	Active
EK Hybrid Zirconia Abutment	EKHZ4041CHT	FDA UDI	Class II	Active
Smartfit Try In Hybrid Denture - 6	TRYHYD06	FDA UDI	Class I	Active
ET Quick Temporary Abutment	ETQTA401MNT	FDA UDI	Class II	Active
ET Angled Abutment_A With EG Screw	ETAGA602SAW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6055SNW	FDA UDI	Class II	Active
ET IV Fixture SA Ultra-Wide No Mount	CET4R7010S	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA5025SP	FDA UDI	Class II	Active
ETIII SA (Ø3.2mm) [ Implant Only ]	ET3M3015S	FDA UDI	Class II	Active
Et Temporary Abutment	ETTPA453SHT	FDA UDI	Class II	Active
Et Freeform St Abutment Set	ETFA6015CWH	FDA UDI	Class II	Active
ET IV Fixture SA Regular Pre-Mounted	AET4R4010S	FDA UDI	Class II	Active
ET Ebony Gold Screw	ETABSSC	FDA UDI	Class I	Active
EK III NH Fixture No Mount	CEK3S7006B	FDA UDI	Class II	Unknown
Et Fixture Transfer Impression Coping	ETTIM4011NC	FDA UDI	Class I	Active
ET IV NH Ultra-Wide Fixture Pre-Mounted	AET4R6007B	FDA UDI	Class II	Active
ET IV NH Fixture Pre-Mounted	AET4R4011B	FDA UDI	Class II	Active
Et Freeform St Abutment	ETFSA701SNW	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI4014MN	FDA UDI	Class I	Active
ET Angled Abutment Set	ETAA6040NCWH	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4054SP	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10ZKMHW	FDA UDI	Class II	Active
ET Angled Abutment_B With EG Screw	ETAGA554SBW	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