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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 2 of 65

Device	Model / Reference	Registries	Class	Status
ET Transfer Abutment Set	ETTA4742CWH	FDA UDI	Class II	Active
ET Multi Angled Abutment	ETMA330SHW	FDA UDI	Class II	Active
Ek Np-Cast Abutment	EKNA4010TH	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4027SP	FDA UDI	Class II	Active
Esthetic-low Plastic Cylinder	ETMEPW100TH	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICR4561HC	FDA UDI	Class I	Active
ET Angled Abutment_B With EG Screw	ETAGA602SBW	FDA UDI	Class II	Active
ET Rigid Burn-out Cylinder	ETRBC60SB	FDA UDI	Class I	Active
ET Bite Impression Coping Hex	ETBICM4430H	FDA UDI	Class I	Active
ET II Fixture SA Regular No-Mounted	CET2R4013S	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4013R28	FDA UDI	Class II	Active
ET Rigid Burn-out Cylinder	ETRP400SC	FDA UDI	Class I	Active
Et Rigid Lab Analog	ETRLA560C	FDA UDI	Class I	Active
ET Healing Abutment	ETHLA4003M	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S5007B	FDA UDI	Class II	Active
ET Multi Ti Base	ETMTB0405G	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA7640NTH	FDA UDI	Class II	Active
Smartfit Final Hybrid Denture - 3	FNLHYD03	FDA UDI	Class I	Active
ET III Fixture SA Regular No Mount	CET3R4511S	FDA UDI	Class II	Active
ET3 D5.5 SA Pre-mounted	AET3R5507S	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R5008R18	FDA UDI	Class II	Active
Et Pick-Up Guide Pin	ETFPG00SL	FDA UDI	Class I	Active
Em Sa Implant (denture)	EMD2015S40	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7065SNW	FDA UDI	Class II	Active
Screw-ZioCera ABT	ETASM	FDA UDI	Class I	Active
Et Fixture Transfer Impression Coping	ETTIS4014NC	FDA UDI	Class I	Active
EK Pre-milled Abutment	EKPMA10ZKNT	FDA UDI	Class II	Active
ET IV NH Fixture No mount	CET4R4508B	FDA UDI	Class II	Active
Multi Abutment NP-Cast Cylinder	ETMNCA500NTH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6077SNW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6074SHW	FDA UDI	Class II	Active
EK Freeform ST Abutment 7.0(3.0), Non-hex	EKFA7030NTH	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4542ONT	FDA UDI	Class II	Active
EK III NH Fixture Pre-Mounted	AEK3S5511B	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR5650HC	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA6025SHW	FDA UDI	Class II	Active
HG II Fixture RBM Regular No Mount	CHG2S4513R	FDA UDI	Class II	Active
HM Implant Narrow Ridge	HMN2513R04	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4621CP	FDA UDI	Class II	Active
EK Freeform ST Abutment 5.0(1.5), Non-hex	EKFA5015NTH	FDA UDI	Class II	Active
ET II Fixture SA Regulsr Pre-Mounted	AET2R5006S	FDA UDI	Class II	Active
ET III Fixture SA Regular No Mount	CET3R5008S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4075MHW	FDA UDI	Class II	Active
Em Sa Implant (narrow Ridge)	EMN2510S40	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI4014MH	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA7660CWH	FDA UDI	Class II	Active
ET IV Fixture SA Ultra-Wide No Mount	CET4R6011S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4535SHW	FDA UDI	Class II	Active
ET Fixture Lab Analog	ETTLA300C	FDA UDI	Class I	Active
ET II Fixture SA Mini No-Mounted	CET2M3515S	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