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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 60 of 65

Device	Model / Reference	Registries	Class	Status
EK Transfer Abutment	EKTA4642TH	FDA UDI	Class II	Active
ET IV NH Ultra-Wide Fixture Pre-Mounted	AET4R7007B	FDA UDI	Class II	Active
Et Ziocera Abutment	ETZCA453SNW	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4650CP	FDA UDI	Class II	Active
Metal sleeve narrow	HOGSCN50S	FDA UDI	Class I	Active
ET Bite Impression Coping Hex	ETBICR4621H	FDA UDI	Class I	Active
ET3 D5.5 SA No mount	CET3R5511S	FDA UDI	Class II	Active
Et Np-Cast Abutment	ETNCA451SHW	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICR5560H	FDA UDI	Class I	Active
ET Convertible Transfer Imp. Coping	ETTIC600C	FDA UDI	Class I	Active
ET Convertible Abutment	ETCA6010CP	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI4511SH	FDA UDI	Class I	Active
EK Bite Impression Coping	EKBIC5440	FDA UDI	Class I	Active
ET Rigid Burn-out Cylinder	ETRBC70SS	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIS7015NAC	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA4575SHW	FDA UDI	Class II	Active
ET Convertible Abutment	ETCA5020CP	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA7460NCWH	FDA UDI	Class II	Active
HG II Fixture RBM Mini No Mount	CHG2M3510R	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA6045SP	FDA UDI	Class II	Active
ET FIXTURE PICK-UP IMPRESSION COPING Mini Hex	ETFTI4017MH	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIM4515NCA	FDA UDI	Class I	Active
ET Angled Abutment(N) With EG Screw	ETAGA454MNW	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4622TH	FDA UDI	Class II	Active
Et Rigid Retraction Cap	ETRRC471C	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA6055SP	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5045SNW	FDA UDI	Class II	Active
Smartfit Try In Hybrid Denture - 1	TRYHYD01	FDA UDI	Class I	Active
HG II Fixture RBM Regular No Mount	CHG2S5008R	FDA UDI	Class II	Active
HG III Fixture RBM Mini No Mount	CHG3M3510R	FDA UDI	Class II	Active
ET Convertible Angled Cylinder	ETAC5080TCWH	FDA UDI	Class I	Active
Et Bite Index	ETBIS5504SC	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA5014SHW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5027SHW	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIM4011CA	FDA UDI	Class I	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R5010R18	FDA UDI	Class II	Active
ET II Fixture SA Regular Pre-Mounted	AET2R4013S	FDA UDI	Class II	Active
ET Healing Abutment Mini, 4.8(D), 6.0(H)	ETHLA4506M	FDA UDI	Class II	Active
EK Healing Abutment	EKHA403	FDA UDI	Class II	Active
ET Quick Temporary Abutment	ETQTA455RNT	FDA UDI	Class II	Active
ET II Fixture SA Regular Pre-Mounted	AET2R5018S	FDA UDI	Class II	Active
ET Healing Abutment	ETHLA7004R	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICM4520HC	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA4631TH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6420CWH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4710CP	FDA UDI	Class II	Active
Ek Fixture Pick-Up Impression Coping	EKPI5016	FDA UDI	Class I	Active
EK Healing Abutment	EKHA603	FDA UDI	Class II	Active
ET IV NH Fixture No mount	CET4R4511B	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4722TH	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