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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 53 of 65

Device	Model / Reference	Registries	Class	Status
Ek Rigid Abutment	EKRA6420P	FDA UDI	Class II	Active
Et Rigid Lab Analog	ETRLA5005S	FDA UDI	Class I	Active
EK Pre-milled Abutment	EKPMA14CANT	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4410P	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4510R18	FDA UDI	Class II	Active
A-graft®[Bone grafting material, Animal source]	HAS010SV	FDA UDI	Class II	Active
Ek Angled Abutment_a	EKAA6040ATH	FDA UDI	Class II	Active
HM Implant Narrow Ridge	HMN3015R03	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4661NCWH	FDA UDI	Class II	Active
Et Ziocera Abutment	ETZCA553SHW	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4450CP	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4534SP	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4543OHT	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4641TH	FDA UDI	Class II	Active
Et Bite Index	ETBIM4504S	FDA UDI	Class I	Active
EK Hybrid Zirconia Abutment	EKHZ4042CNT	FDA UDI	Class II	Active
ET Angled Abutment	ETAA6040AC	FDA UDI	Class II	Active
ET Multi Angled Abutment	ET30MAM4850CWH	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA5430P	FDA UDI	Class II	Active
ET III Fixture NH Regular [ Implant Only ]	ET3R5010B	FDA UDI	Class II	Active
ET Multi Angled Abutment	ET17MAM4830CWH	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC5640H	FDA UDI	Class I	Active
EK III SA Fixture No Mount	CEK3S4008S	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4751CP	FDA UDI	Class II	Active
Et Freeform St Abutment	ETFSAS503SHW	FDA UDI	Class II	Active
ET cover screw Mini (D) 3.0	ETCS30	FDA UDI	Class II	Active
Et Rigid Lab Analog	ETRLA5004S	FDA UDI	Class I	Active
ET Hybrid Abutment	ETCMARNZS	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4720CP	FDA UDI	Class II	Active
ET III Fixture BA Regular Pre-Mounted	AET3R4511B	FDA UDI	Class II	Active
ET III Fixture SA Regular Pre-Mounted	AET3R5007S	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA7650NTH	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10HURNW	FDA UDI	Class II	Active
Esthetic-low Pick-Up Impression Coping Guide Pin	ETGP170	FDA UDI	Class I	Active
Et Freeform St Abutment Set	ETFA7030CWH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5027SNW	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA7430NTH	FDA UDI	Class II	Active
Ek Ti Abutment Screw	EKABST	FDA UDI	Class I	Active
Ek Fixture Transfer Impression Coping	EKTI4514N	FDA UDI	Class I	Active
HG III Fixture RBM Regular No Mount	CHG3S4511R	FDA UDI	Class II	Active
EK Freeform ST Abutment 4.0(1.5), Non-hex	EKFA4015NTH	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5750TH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4555SNW	FDA UDI	Class II	Active
ET Convertible Pick-up Impression Coping	ETPIC400C	FDA UDI	Class I	Active
Et Rigid Protect Cap	ETRPC640C	FDA UDI	Class I	Active
HG III Ultra-Wide Fixture RBM Pre-Mounted	AHG3S6008R	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA14MXRHW	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S6010B	FDA UDI	Class II	Active
HG II Ultra-Wide Fixture RBM Pre-Mounted	AHG2S6007R	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC5440H	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