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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 39 of 65

Device	Model / Reference	Registries	Class	Status
EK III SA Fixture No Mount	CEK3S3008S	FDA UDI	Class II	Unknown
ET III Fixture BA Regular Pre-Mounted	AET3R4015B	FDA UDI	Class II	Active
ET Multi Angled Abutment	ETMA330MHW	FDA UDI	Class II	Active
Et Freeform St Abutment	ETFSA403SNW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5075SNW	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4044OHT	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10UKMNW	FDA UDI	Class II	Active
ET Angled Abutment_B With EG Screw	ETAGA454MBW	FDA UDI	Class II	Active
ET III Fixture NH Mini D3.2 No Mount	CET3M3013B	FDA UDI	Class II	Active
ET Convertible Abutment	ETCA5050CP	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4525SNW	FDA UDI	Class II	Active
ET III Fixture SA Regular [ Implant Only]	ET3R4508S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4611CWH	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10ZKRHW	FDA UDI	Class II	Active
ET III Fixture SA Regular No Mount	CET3R4013S	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S6008B	FDA UDI	Class II	Unknown
EK III NH Fixture Pre-Mounted	AEK3S6006B	FDA UDI	Class II	Active
Em Sa Implant (denture)	EMD2010S20	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA7045SP	FDA UDI	Class II	Active
Bite Impression Coping Driver	ETOICDR	FDA UDI	Class I	Active
HG III Ultra-Wide Fixture RBM Pre-Mounted	AHG3S6007R	FDA UDI	Class II	Active
ET Abutment Laboratory Screw	ETABSSWC	FDA UDI	Class I	Active
HG II Fixture Regular RBM Pre-Mounted	AHG2S4513R	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5440TH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5720NTH	FDA UDI	Class II	Active
ET Angled Abutment	ETAA4540BC	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4711CP	FDA UDI	Class II	Active
ET cover screw Regular	ETCS40S-G	FDA UDI	Class II	Active
HG II Fixture RBM Regular No Mount	CHG2S5007R	FDA UDI	Class II	Active
ET IV Fixture SA Ultra-Wide Pre-Mounted	AET4R6007S	FDA UDI	Class II	Active
ET3 D5.5 SA No mount	CET3R5513S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4652CWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4671CWH	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4451H	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA4537MP	FDA UDI	Class II	Active
ET III Fixture SA Regular [ Implant Only]	ET3R4011S	FDA UDI	Class II	Active
ET Ebony Gold Cylinder Screw	ETFSMC	FDA UDI	Class I	Active
Et Fixture Transfer Impression Coping	ETFTI7011SH	FDA UDI	Class I	Active
ET IV NH Fixture No mount	CET4R5008B	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA14ZKMNW	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S7006B	FDA UDI	Class II	Active
Et Temporary Abutment	ETTPA401MHT	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4044CNT	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICM4651H	FDA UDI	Class I	Active
Ek Rigid Abutment	EKRA5730P	FDA UDI	Class II	Active
ET Scan Post - Cerec	ETCSPMHL	FDA UDI	Class I	Active
EK III SA Fixture No Mount	CEK3S3513S	FDA UDI	Class II	Active
ET IV NH Ultra-Wide Fixture Pre-Mounted	AET4R6008B	FDA UDI	Class II	Active
HM Implant Narrow Ridge	HMN2510R03	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S3011B	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