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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 9 of 65

Device	Model / Reference	Registries	Class	Status
Et Rigid Lab Analog	ETRLA460C	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA4014MP	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICM4431H	FDA UDI	Class I	Active
ET Rigid Abutment SET	ETRA5640CP	FDA UDI	Class II	Active
Ek Fixture Transfer Impression Coping	EKTI4014N	FDA UDI	Class I	Active
ET Pre-milled Abutment	ETPMA14CAMHW	FDA UDI	Class II	Active
Ek Fixture Transfer Impression Coping	EKTI5011	FDA UDI	Class I	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R5010R28	FDA UDI	Class II	Active
HG II Fixture Mini RBM Pre-Mounted	AHG2M3515R	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4621	FDA UDI	Class I	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4011R28	FDA UDI	Class II	Active
ET III NH Ultra-Wide Fixture No-Mount	CET3R6007B	FDA UDI	Class II	Active
Et Rigid Impression Coping	ETRIC441SC	FDA UDI	Class I	Active
Et Fixture Transfer Impression Coping	ETTIM4014C	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICM4621HC	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA7440CWH	FDA UDI	Class II	Active
ET Angled Abutment_B With EG Screw	ETAGA452SBW	FDA UDI	Class II	Active
ET Convertible GoldCast Cylinder	ETGC600CWH	FDA UDI	Class I	Active
ET III Fixture SA Regular No Mount	CET3R5006S	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4731CP	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6014SHW	FDA UDI	Class II	Active
Ek Np-Cast Abutment	EKNA4530NTH	FDA UDI	Class II	Active
ET III Fixture BA Mini Pre-Mounted	AET3M3513B	FDA UDI	Class II	Active
Ek Stud Abutment Normal	EKSA3520	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4640P	FDA UDI	Class II	Active
ET Scan body(Intraoral)	ETNSBMLTH	FDA UDI	Class I	Active
Ek Transfer Abutment	EKTA6610TH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6067SNW	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC5650	FDA UDI	Class I	Active
Ek Rigid Abutment	EKRA6650P	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4660HC	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA4711CWH	FDA UDI	Class II	Active
Em Sa Implant (narrow Ridge)	EMN3008S25	FDA UDI	Class II	Active
Et Stud Abutment Set	ETSAO351M	FDA UDI	Class II	Active
ET III Fixture SA Regular No Mount	CET3R4007S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5025SHW	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4064CHT	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS4015CA	FDA UDI	Class I	Active
ET Multi Angled Abutment	ETMA517SHW	FDA UDI	Class II	Active
ET III Fixture SA Regular [ Implant Only]	ET3R4010S	FDA UDI	Class II	Active
Bite Impression Coping (Mini)	ETBICM4650	FDA UDI	Class I	Active
Em Sa Implant (denture)	EMD2515S20	FDA UDI	Class II	Active
Bite Impression Coping (Mini)	ETBICM4621	FDA UDI	Class I	Active
EK III SA Fixture No Mount	CEK3S5011S	FDA UDI	Class II	Active
Et Rigid Protect Cap	ETRPC4007	FDA UDI	Class I	Active
ET III Fixture NH Regular No-Mounted	CET3R5011B	FDA UDI	Class II	Active
ET III SA Ultra-Wide Fixture No Mount	CET3R6007S	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4542CHT	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS4011NCA	FDA UDI	Class I	Active
Fixture Lab Analog	ETFLAS	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