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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 29 of 65

Device	Model / Reference	Registries	Class	Status
Smartfit Bone Reduction Guide 7 Holes	ETSGBR07	FDA UDI	Class I	Active
EK Pre-milled Abutment	EKPMA10CANT	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S3010S	FDA UDI	Class II	Active
Et Freeform St Abutment Set	ETFAM4015NCWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5410NCWH	FDA UDI	Class II	Active
EK Healing Abutment	EKHA706	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10ANRNW	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI4015SH	FDA UDI	Class I	Active
Multi Abutment NP-Cast Cylinder	ETMNCA500TH	FDA UDI	Class II	Active
ET III NH Ultra-Wide Fixture No-Mount	CET3R6013B	FDA UDI	Class II	Active
Ek Bite Index	EKBI5508S	FDA UDI	Class I	Active
HS II Fixture Wide RBM Pre-Mounted	AHS2W4515R20	FDA UDI	Class II	Active
ET III Fixture NH Mini [ Implant Only ]	ET3M3515B	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5710TH	FDA UDI	Class II	Active
Em Sa Implant (denture)	EMD3010S40	FDA UDI	Class II	Active
Ek Angled Abutment_b	EKAA4040BTH	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4731P	FDA UDI	Class II	Active
Hiossen Ti Abutment Laboratory Screw	ETABSSL	FDA UDI	Class I	Active
ET Hybrid Abutment	ETCMAMHZS	FDA UDI	Class II	Active
HG III Fixture RBM Mini Pre-Mounted	AHG3M3508R	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4514MP	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6055SHW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5440CWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5670NCWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6730CWH	FDA UDI	Class II	Active
ET III SA Ultra-Wide Fixture Pre-Mounted	AET3R7013S	FDA UDI	Class II	Active
ET cover screw Mini (D) 3.0, Long	ETCS30L	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA6017SP	FDA UDI	Class II	Active
ET Multi Abutment	ETMTA505M	FDA UDI	Class II	Active
HG II Fixture Regular RBM Pre-Mounted	AHG2S4011R	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4410CP	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4575MHW	FDA UDI	Class II	Active
EM Provisional	EMT18104	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S3011B	FDA UDI	Class II	Unknown
ET Bite Impression Coping	ETBICM4561HC	FDA UDI	Class I	Active
ET Rigid Burn-out Cylinder	ETRBC45B	FDA UDI	Class I	Active
ET IV NH Fixture Pre-Mounted	AET4R5008B	FDA UDI	Class II	Active
ET IV NH Fixture No mount	CET4R4007B	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI4514MH	FDA UDI	Class I	Active
EK Hybrid Zirconia Abutment	EKHZ4563CNT	FDA UDI	Class II	Active
ET Custom Healing Abutment	ETHLAP7M	FDA UDI	Class II	Active
EK Healing Abutment	EKHA457	FDA UDI	Class II	Active
ET3 D5.5 SA No mount	CET3R5507S	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICM4641HC	FDA UDI	Class I	Active
Bite Impression Coping (Mini)	ETBICM4450	FDA UDI	Class I	Active
ET Convertible Abutment	ETCA4030CP	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6057SHW	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA5720CP	FDA UDI	Class II	Active
Smartfit Try In Hybrid Denture - 9	TRYHYD09	FDA UDI	Class I	Active
Ek Fixture Pick-Up Impression Coping	EKPI4516N	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