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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 6 of 65

Device	Model / Reference	Registries	Class	Status
ET Transfer Abutment	ETTA4057MHW	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA14ZKMHW	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA7640CP	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4524MP	FDA UDI	Class II	Active
Ek Angled Abutment_a	EKAA4040ATH	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4450HC	FDA UDI	Class I	Active
ET Angled Abutment_B With EG Screw	ETAGA454SBW	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R5013R18	FDA UDI	Class II	Active
Et Pick-Up Guide Pin	ETFPG00M	FDA UDI	Class I	Active
ET Multi Ti Base	ETMTB0410G	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC5430H	FDA UDI	Class I	Active
EK III NH Fixture Pre-Mounted	AEK3S3008B	FDA UDI	Class II	Unknown
EK Transfer Abutment	EKTA4651NTH	FDA UDI	Class II	Active
EM Provisional	EMT25154	FDA UDI	Class II	Active
Hiossen	AET3M3508B	FDA UDI	Class II	Active
ET Healing Abutment Regular, 7.3(D), 6.0(H)	ETHLA7006R	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6054SHW	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4641CP	FDA UDI	Class II	Active
HG III Fixture RBM Regular No Mount	CHG3S5010R	FDA UDI	Class II	Active
ET O-ring Retainer Set	ETRS01	FDA UDI	Class I	Active
SMARTFIT TRY IN HYBRID DENTURE - No Hole	TRYHYD00	FDA UDI	Class II	Active
ET Convertible Temporary Cylinder	ETCTC400TNCTH	FDA UDI	Class I	Active
ET Angled Abutment Set	ETAA4040MACWH	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4014SP	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4557SHW	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4544OHT	FDA UDI	Class II	Active
HG III Fixture RBM Regular Pre-Mounted	AHG3S4515R	FDA UDI	Class II	Active
ET III Fixture SA Regular No Mount	CET3R4515S	FDA UDI	Class II	Active
ET III Fixture NH Mini [ Implant Only ]	ET3M3513B	FDA UDI	Class II	Active
ET III Fixture BA Regular Pre-Mounted	AET3R4508B	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4440P	FDA UDI	Class II	Active
ET IV NH Ultra-Wide Fixture No mount	CET4R6011B	FDA UDI	Class II	Active
Et Rigid Impression Coping	ETRIC5005S	FDA UDI	Class I	Active
ET IV Fixture SA Regular Pre-Mounted	AET4R5010S	FDA UDI	Class II	Active
Fixture Lab Analog	ETFLAM3	FDA UDI	Class I	Active
ET IV Fixture SA Regular Pre-Mounted	AET4R5008S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6620CWH	FDA UDI	Class II	Active
EK Pre-milled Abutment	EKPMA10ARNT	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR4661H	FDA UDI	Class I	Active
EK Pre-milled Abutment	EKPMA14ZKHT	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4540HC	FDA UDI	Class I	Active
Smartfit Try In Hybrid Denture - 2	TRYHYD02	FDA UDI	Class I	Active
ET Pre-milled Abutment	ETPMA12CERNW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4567MNW	FDA UDI	Class II	Active
ET III NH Ultra-Wide Fixture Pre-Mount	AET3R6007B	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA7670CWH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5640NTH	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS5015AC	FDA UDI	Class I	Active
Et Freeform St Abutment	ETFSA701SHW	FDA UDI	Class II	Active
ET Scan body(Intraoral)	ETNSBRLTH	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