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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 14 of 65

Device	Model / Reference	Registries	Class	Status
ET III Fixture BA Regular Pre-Mounted	AET3R4507B	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S3513B	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4420CP	FDA UDI	Class II	Active
HM Implant Denture	HMD3013R04	FDA UDI	Class II	Active
ET III Fixture SA Regular Pre-Mounted	AET3R4511S	FDA UDI	Class II	Active
Bite Impression Coping	ETBICR5440	FDA UDI	Class I	Active
EK III NH Fixture No Mount	CEK3S6011B	FDA UDI	Class II	Unknown
ET Convertible Plastic Cylinder	ETCPL400CWH	FDA UDI	Class I	Active
EK III NH Fixture No Mount	CEK3S4011B	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4732TH	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4515R28	FDA UDI	Class II	Active
ET Abutment Screw, Mini	ETFSMTC	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA4517SP	FDA UDI	Class II	Active
Et Freeform St Abutment Set	ETFA6015NCWH	FDA UDI	Class II	Active
Esthetic-low Temporary Abutment	ETNMTR200TH	FDA UDI	Class I	Active
HS II Fixture Wide RBM Pre-Mounted	AHS2W5011R20	FDA UDI	Class II	Active
ETIII SA (Ø3.2mm) Pre-mounted	AET3M3011S	FDA UDI	Class II	Active
ET IV NH Fixture Pre-Mounted	AET4R5013B	FDA UDI	Class II	Active
HG III Fixture RBM Regular Pre-Mounted	AHG3S5015R	FDA UDI	Class II	Active
HM Implant Denture	HMD2515R02	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI4020MH	FDA UDI	Class I	Active
Ek Fixture Transfer Impression Coping	EKTI4514	FDA UDI	Class I	Active
Et Pick-Up Guide Pin	ETFPG05S	FDA UDI	Class I	Active
ET Angled Abutment Set	ETAA6040ACWH	FDA UDI	Class II	Active
HG III Fixture RBM Regular No Mount	CHG3S4010R	FDA UDI	Class II	Active
ET II Fixture SA Regular Pre-Mounted	AET2R4018S	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5610NTH	FDA UDI	Class II	Active
ET IV Fixture SA Regular No Mount	CET4R5011S	FDA UDI	Class II	Active
Ek Fixture Transfer Impression Coping	EKTI6014	FDA UDI	Class I	Active
ET Gold Cast Abutment SET	ETGA4030SCWH	FDA UDI	Class II	Active
ET Angled Abutment	ETAA5020BC	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA5750CP	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI5011SH	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICM4560HC	FDA UDI	Class I	Active
Et Rigid Retraction Cap	ETRRC760	FDA UDI	Class I	Active
HG III Fixture RBM Regular Pre-Mounted	AHG3S4011R	FDA UDI	Class II	Active
ET III Fixture NH Regular Pre-Mounted	AET3R5010B	FDA UDI	Class II	Active
ET Convertible Pick-up Guide Pin	ETCGP500SC	FDA UDI	Class I	Active
ET Pre-milled Abutment	ETPMA12CEMHW	FDA UDI	Class II	Active
ET Quick Temporary Abutment	ETQTA405MNT	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA14MXMNW	FDA UDI	Class II	Active
EK Fixture Pick up Guide pin	EKPGP200	FDA UDI	Class I	Active
Em Sa Implant (denture)	EMD2013S40	FDA UDI	Class II	Active
Screw-Multi Angled ABT	ETMABSS	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA5057SP	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S6013S	FDA UDI	Class II	Unknown
Et Stud Abutment	ETSAO354M	FDA UDI	Class II	Active
EK Digital Lab Analog Positioning JIG	EKDLAPJ	FDA UDI	Class I	Active
ET Multi Angled Abutment	ETMA530SHW	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S5510S	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