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HIOSSEN INC.

US

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 49 of 65
DeviceModel / ReferenceRegistriesClassStatus
ET Angled Abutment_A With EG Screw ETAGA554SAW
FDA UDI
Class IIActive
ET III Fixture BA Regular Pre-Mounted AET3R5011B
FDA UDI
Class IIActive
Et Ziocera Angled Abutment ETZAA654SNW
FDA UDI
Class IIActive
Et Rigid Retraction Cap ETRRC560
FDA UDI
Class IActive
ET Convertible Combination Cylinder ETCC6070TCWH
FDA UDI
Class IActive
ET Fixture Lab Analog ETTLA350C
FDA UDI
Class IActive
ET Esthetic-low Pick-Up Impression Coping ETMSR200C
FDA UDI
Class IActive
HG II Fixture RBM Regular No Mount CHG2S4515R
FDA UDI
Class IIActive
ET Transfer Abutment ETTA5014SNW
FDA UDI
Class IIActive
Et Pick-Up Guide Pin ETPGPM150LC
FDA UDI
Class IActive
ET Transfer Abutment ETTA6057SNW
FDA UDI
Class IIActive
ET Rigid Abutment ETRGA6024SP
FDA UDI
Class IIActive
ET III Fixture NH Regular Pre-Mounted AET3R4507B
FDA UDI
Class IIActive
ET Transfer Abutment Set ETTA5770CWH
FDA UDI
Class IIActive
ET Transfer Abutment ETTA5024SHW
FDA UDI
Class IIActive
ET Bite Impression Coping Hex ETBICM4631H
FDA UDI
Class IActive
EK Transfer Abutment EKTA4711TH
FDA UDI
Class IIActive
HG III Fixture RBM Regular Pre-Mounted AHG3S4013R
FDA UDI
Class IIActive
ET Rigid Abutment SET ETRA4421CP
FDA UDI
Class IIActive
Et Fixture Transfer Impression Coping ETTIM4011C
FDA UDI
Class IActive
ET Transfer Abutment Set ETTA6740NCWH
FDA UDI
Class IIActive
EK III SA Fixture No Mount CEK3S4507S
FDA UDI
Class IIActive
EK Transfer Abutment EKTA5630TH
FDA UDI
Class IIActive
ET III Fixture NH Regular [ Implant Only ] ET3R4015B
FDA UDI
Class IIActive
ET Pre-milled Abutment ETPMA14ARMNW
FDA UDI
Class IIActive
ET IV Fixture SA Regular No Mount CET4R5007S
FDA UDI
Class IIActive
EK III NH Fixture Pre-Mounted AEK3S3007B
FDA UDI
Class IIActive
ET O-ring Set (Small) ETOAON01S
FDA UDI
Class IActive
ET Multi Abutment ETMTA502M
FDA UDI
Class IIActive
ET Multi Ti Base Screw ETMTBS
FDA UDI
Class IIActive
Et Stud Abutment ETSA3520C
FDA UDI
Class IIActive
ET Transfer Abutment Set ETTA6430CWH
FDA UDI
Class IIActive
EK III SA Fixture No Mount CEK3S5008S
FDA UDI
Class IIActive
Et Fixture Pick-Up Impression Coping ETPIM4515AC
FDA UDI
Class IActive
ET II Fixture SA Regular No-Mounted CET2R4008S
FDA UDI
Class IIActive
ET Rigid Abutment ETRGA4525MP
FDA UDI
Class IIActive
EK III NH Fixture Pre-Mounted AEK3S6007B
FDA UDI
Class IIUnknown
ET Angled Abutment ETAA5020NCWH
FDA UDI
Class IIActive
Et Rigid Lab Analog ETRLA4504
FDA UDI
Class IActive
ET Pre-milled Abutment ETPMA14ANMNW
FDA UDI
Class IIActive
Et Rigid Protect Cap ETRPC4505
FDA UDI
Class IActive
EK III NH Fixture Pre-Mounted AEK3S3513B
FDA UDI
Class IIActive
Et Rigid Impression Coping ETRIC471SC
FDA UDI
Class IActive
ET III Fixture BA Regular Pre-Mounted AET3R4007B
FDA UDI
Class IIActive
Et Stud Abutment ETSAO354S
FDA UDI
Class IIActive
Et Rigid Protect Cap ETRPC471C
FDA UDI
Class IActive
Ek Rigid Abutment EKRA4620P
FDA UDI
Class IIActive
EK III NH Fixture No Mount CEK3S4510B
FDA UDI
Class IIActive
EK Transfer Abutment EKTA6750NTH
FDA UDI
Class IIActive
ET EsthTSic-low Gold Cylinder STS ETMGR100CTH
FDA UDI
Class IActive

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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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.

DateRecall No.ClassStatusReason
Jan 27, 2025Z-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, 2025Z-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, 2025Z-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, 2025Z-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, 2025Z-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, 2025Z-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