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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: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3007135442
DUNS Number: —

Catalogue (3217)

Page 22 of 65

Device	Model / Reference	Registries	Class	Status
ET III SA Ultra-Wide Fixture Pre-Mounted	AET3R7007S	FDA UDI	Class II	Active
ET IV Fixture SA Ultra-Wide Pre-Mounted	AET4R7008S	FDA UDI	Class II	Active
ET III Fixture NH Regular No-Mounted	CET3R4511B	FDA UDI	Class II	Active
A-graft®[Bone grafting material, Animal source]	HAS050LV	FDA UDI	Class II	Active
ET Healing Abutment	ETHLA4007M	FDA UDI	Class II	Active
EK Freeform ST Abutment Straight 5.0(1.5), Non-hex	EKFAS5015NTH	FDA UDI	Class II	Active
HG II Fixture RBM Regular No Mount	CHG2S4510R	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS5011NAC	FDA UDI	Class I	Active
Et Rigid Impression Coping	ETRIC4504S	FDA UDI	Class I	Active
Ek Fixture Transfer Impression Coping	EKTI6014N	FDA UDI	Class I	Active
ET IV NH Ultra-Wide Fixture No mount	CET4R7010B	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS6015NAC	FDA UDI	Class I	Active
Ek Abutment Laboratory Waxing Screw	EKABSW	FDA UDI	Class I	Active
ET II Fixture SA Mini Pre-Mounted	AET2M3518S	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5420TH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4525MNW	FDA UDI	Class II	Active
ET II Fixture SA Regular No-Mounted	CET2R4515S	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA6720TH	FDA UDI	Class II	Active
Et Stud Abutment	ETSA3550C	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4722NCWH	FDA UDI	Class II	Active
Ek Fixture Pick-Up Impression Coping	EKPI4516	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA6730TH	FDA UDI	Class II	Active
EK Healing Abutment	EKHA455	FDA UDI	Class II	Active
ET III Fixture SA Regular Pre-Mounted	AET3R4518S	FDA UDI	Class II	Active
ET Rigid Burn-out Cylinder	ETRP500BC	FDA UDI	Class I	Active
ET EsthTSic-low Lab Analog	ETMERW300C	FDA UDI	Class I	Active
ET IV NH Fixture Pre-Mounted	AET4R4010B	FDA UDI	Class II	Active
ET II Fixture SA Regular No-Mounted	CET2R5006S	FDA UDI	Class II	Active
Et Rigid Retraction Cap	ETRRC640C	FDA UDI	Class I	Active
EK Pre-milled Abutment	EKPMA10ANHT	FDA UDI	Class II	Active
Hiossen	AET3M3008S	FDA UDI	Class II	Active
HM Implant Denture	HMD2513R04	FDA UDI	Class II	Active
HG II Fixture RBM Mini No Mount	CHG2M3513R	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S6010S	FDA UDI	Class II	Active
ET Convertible Protect Cap	ETCHC600CWH	FDA UDI	Class I	Active
EK III NH Fixture No Mount	CEK3S6007B	FDA UDI	Class II	Active
Et Rigid Lab Analog	ETRLA640C	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICR5450HC	FDA UDI	Class I	Active
Ek Angled Abutment(n)	EKAA4020NTH	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S3510B	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4421HC	FDA UDI	Class I	Active
Smartfit Try In Hybrid Denture - 10	TRYHYD10	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA4535SNW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6054SNW	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI4011SN	FDA UDI	Class I	Active
Esthetic-low Temporary Abutment	ETNMTW100TH	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA5057SNW	FDA UDI	Class II	Active
Ek Transfer Abutment	EKTA6620NTH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4761CWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4761CWH	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