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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 44 of 65

Device	Model / Reference	Registries	Class	Status
ET Bite Impression Coping	ETBICR4541HC	FDA UDI	Class I	Active
Bite Impression Coping (Mini)	ETBICM4421	FDA UDI	Class I	Active
ET Rigid Abutment SET	ETRA5610CP	FDA UDI	Class II	Active
EK Pre-milled Abutment	EKPMA10ARHT	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S7013B	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI4017MH	FDA UDI	Class I	Active
Esthetic-low Plastic Cylinder	ETMEPR200TH	FDA UDI	Class I	Active
ET III Fixture NH Regular Pre-Mounted	AET3R5008B	FDA UDI	Class II	Active
HS II Fixture Wide RBM Pre-Mounted	AHS2W4508R20	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR5460H	FDA UDI	Class I	Active
ET Convertible Angled Cylinder	ETAC4080TCWH	FDA UDI	Class I	Active
Screw-Custom Healing ABT	ETCHABSST	FDA UDI	Class II	Active
Et Rigid Impression Coping	ETRIC670SC	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA4545MP	FDA UDI	Class II	Active
ET Multi Angled Abutment	ET17MAS4830CWH	FDA UDI	Class II	Active
ET Esthetic-low Pick-Up Impression Coping Guide Pin	ETGP100C	FDA UDI	Class I	Active
EK Healing Abutment	EKHA409	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S6007B	FDA UDI	Class II	Unknown
ET Transfer Abutment	ETTA5024SNW	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA6750CP	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4535MNW	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S4513S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5610NCWH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5065SNW	FDA UDI	Class II	Active
Esthetic-low Plastic Cylinder	ETMEPW200TH	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA6640NCWH	FDA UDI	Class II	Active
ET Rigid Burn-out Cylinder	ETRP450SC	FDA UDI	Class I	Active
Et Fixture Transfer Impression Coping	ETFTI4011MH	FDA UDI	Class I	Active
Smartfit Ek Mua Sn Ek Mua Standaed Non Hex	EKCMAMASN	FDA UDI	Class I	Active
EK III NH Fixture Pre-Mounted	AEK3S5013B	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6067SHW	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETTIS7011C	FDA UDI	Class I	Active
HG II Fixture Regular RBM Pre-Mounted	AHG2S4510R	FDA UDI	Class II	Active
ET Hybrid Abutment	ETCMARHZS	FDA UDI	Class II	Active
ET III Fixture BA Regular Pre-Mounted	AET3R4510B	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S4007B	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA7640TH	FDA UDI	Class II	Active
ET Angled Abutment Set	ETAA5040NCWH	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI4011SH	FDA UDI	Class I	Active
ET II Fixture SA Regular No-Mounted	CET2R4510S	FDA UDI	Class II	Active
ET IV Fixture SA Regular Pre-Mounted	AET4R4007S	FDA UDI	Class II	Active
Et Rigid Retraction Cap	ETRRC660C	FDA UDI	Class I	Active
EK Freeform ST Abutment 5.0(1.5), Hex	EKFA5015TH	FDA UDI	Class II	Active
ET Convertible Abutment	ETCA6050CP	FDA UDI	Class II	Active
ET III Fixture NH Regular Pre-Mounted	AET3R4013B	FDA UDI	Class II	Active
HG II Ultra-Wide Fixture	CHG2S7011R	FDA UDI	Class II	Active
ET Angled Abutment	ETAA4020MACWH	FDA UDI	Class II	Active
HG II Fixture Regular RBM Pre-Mounted	AHG2S4508R	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4641	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIM4015NCA	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