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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 5 of 65

Device	Model / Reference	Registries	Class	Status
Em Sa Implant (denture)	EMD2508S20	FDA UDI	Class II	Active
Et Rigid Protect Cap	ETRPC5005S	FDA UDI	Class I	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4007R18	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S3013S	FDA UDI	Class II	Unknown
Et Fixture Transfer Impression Coping	ETFTI6014SN	FDA UDI	Class I	Active
Ek Bite Index	EKBI5510S	FDA UDI	Class I	Active
EK Bite Impression Coping	EKBIC5630	FDA UDI	Class I	Active
ET III Fixture SA Mini No Mount	CET3M3508S	FDA UDI	Class II	Active
EK New scan body	EKNSBETH	FDA UDI	Class I	Active
ET Angled Abutment_B With EG Screw	ETAGA432MBW	FDA UDI	Class II	Active
Et Pick-Up Guide Pin	ETFPG00S	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA4037SP	FDA UDI	Class II	Active
Et Freeform St Abutment Set	ETFAS5015CWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4741CWH	FDA UDI	Class II	Active
ET III NH Ultra-Wide Fixture No-Mount	CET3R7013B	FDA UDI	Class II	Active
ET II Fixture SA Regular No-Mounted	CET2R4018S	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4043CHT	FDA UDI	Class II	Active
ET Custom Healing Abutment	ETHLAP9R	FDA UDI	Class II	Active
ET III SA Ultra-Wide Fixture Pre-Mounted	AET3R6008S	FDA UDI	Class II	Active
ET IV NH Ultra-Wide Fixture No mount	CET4R7011B	FDA UDI	Class II	Active
ET III Fixture NH Regular Pre-Mounted	AET3R4513B	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4440CP	FDA UDI	Class II	Active
Smartfit Try In Hybrid Denture - 4	TRYHYD04	FDA UDI	Class I	Active
HS II Fixture Wide RBM Pre-Mounted	AHS2W5007R20	FDA UDI	Class II	Active
Et Ziocera Abutment	ETZCA455MHW	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4741P	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA7015SP	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4751TH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4411CP	FDA UDI	Class II	Active
ET III Fixture SA Mini Pre-Mounted	AET3M3508S	FDA UDI	Class II	Active
ET Angled Abutment	ETAA5040AC	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6760CWH	FDA UDI	Class II	Active
A-Oss®	AOSN200LV	FDA UDI	Class II	Unknown
ET Rigid Burn-out Cylinder	ETRBC45S	FDA UDI	Class I	Active
HS II Fixture Wide RBM Pre-Mounted	AHS2W5015R20	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIM4511NCA	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA5720NCWH	FDA UDI	Class II	Active
Ek Fixture Pick-Up Impression Coping	EKPI6016N	FDA UDI	Class I	Active
EK III NH Fixture Pre-Mounted	AEK3S7013B	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4741NTH	FDA UDI	Class II	Active
EK Healing Abutment	EKHA454	FDA UDI	Class II	Active
ET III Fixture SA Regular Pre-Mounted	AET3R5015S	FDA UDI	Class II	Active
ET FIXTURE PICK-UP IMPRESSION COPING Mini Non-Hex	ETFTI4017MN	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETFPI5020MH	FDA UDI	Class I	Active
Et Ziocera Abutment	ETZCA453SHW	FDA UDI	Class II	Active
ET Multi Ti Base Set	ETTSMTB0410GCTH	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA4045MP	FDA UDI	Class II	Active
ET III SA Ultra-Wide Fixture No Mount	CET3R7007S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA7670NCWH	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S3007S	FDA UDI	Class II	Unknown

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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