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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 27 of 65

Device	Model / Reference	Registries	Class	Status
ET FIXTURE PICK-UP IMPRESSION COPING Regular Non-Hex	ETFTI5020SN	FDA UDI	Class I	Active
ET III Fixture NH Mini D3.2 No Mount	CET3M3011B	FDA UDI	Class II	Active
ET Multi Abutment	ETMA5050MCP	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4042CHT	FDA UDI	Class II	Active
ET Convertible Pick-up Impression Coping	ETPIC500C	FDA UDI	Class I	Active
ET Quick Temporary Abutment	ETQTA455MHT	FDA UDI	Class II	Active
ET Multi Angled Abutment	ET30MAS4850CWH	FDA UDI	Class II	Active
Bite Impression Coping (Mini)	ETBICM4441	FDA UDI	Class I	Active
ET Multi Abutment	ETMTA505R	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICM4550HC	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIS5015NCA	FDA UDI	Class I	Active
EK Bite Impression Coping	EKBIC4441	FDA UDI	Class I	Active
ET3 D5.5 SA No mount	CET3R5510S	FDA UDI	Class II	Active
ET cover screw Mini, Long	ETCS35L	FDA UDI	Class II	Active
ET Angled Abutment Set	ETAA4020MBCWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA5630NCWH	FDA UDI	Class II	Active
ET EsthTSic-low Lab Analog	ETMERR300C	FDA UDI	Class I	Active
ET IV Fixture SA Ultra-Wide Pre-Mounted	AET4R7007S	FDA UDI	Class II	Active
ET3 D5.5 NH No mount	CET3R5513B	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4771NCWH	FDA UDI	Class II	Active
Ek Multi Abutment	EKMA5050P	FDA UDI	Class II	Active
ET FIXTURE PICK-UP IMPRESSION COPING Mini Non-Hex	ETFTI4020MN	FDA UDI	Class I	Active
A-graft®[Bone grafting material, Animal source]	HAS100SV	FDA UDI	Class II	Active
ET EsthTSic-low Transfer Impression Coping	ETMTTR100C	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA4772NCWH	FDA UDI	Class II	Active
ET III Fixture SA Regular Pre-Mounted	AET3R4508S	FDA UDI	Class II	Active
Et Np-Cast Abutment	ETNCA401MHW	FDA UDI	Class II	Active
ET III Fixture NH Regular [ Implant Only ]	ET3R4007B	FDA UDI	Class II	Active
Et Ziocera Angled Abutment	ETZAA553SNW	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4621TH	FDA UDI	Class II	Active
A-Oss®	AOSN100SV	FDA UDI	Class II	Unknown
HG II Fixture RBM Regular No Mount	CHG2S4008R	FDA UDI	Class II	Active
Ek Angled Abutment(n)	EKAA6040NTH	FDA UDI	Class II	Active
ET III Fixture SA Regular No Mount	CET3R4513S	FDA UDI	Class II	Active
ET Convertible Abutment	ETCAS4030CP	FDA UDI	Class II	Active
ET3 D5.5 NH No mount	CET3R5510B	FDA UDI	Class II	Active
ET Multi Angled Abutment	ETMA430MHW	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4542CNT	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA6640P	FDA UDI	Class II	Active
ET III NH Ultra-Wide Fixture No-Mount	CET3R7007B	FDA UDI	Class II	Active
A-Oss®	AOSN200SV	FDA UDI	Class II	Unknown
ET Rigid Abutment	ETRGA4015MP	FDA UDI	Class II	Active
EK Freeform ST Abutment 7.0(1.5), Hex	EKFA7015TH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7044SHW	FDA UDI	Class II	Active
ET Scan Post - Cerec	ETCSPRHL	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA4641CWH	FDA UDI	Class II	Active
ET Convertible Abutment	ETCA5010CP	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4621CWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6410NCWH	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S6008B	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