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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 4 of 65
DeviceModel / ReferenceRegistriesClassStatus
Et Ziocera Abutment ETZCA653SNW
FDA UDI
Class IIActive
ET IV NH Fixture Pre-Mounted AET4R4507B
FDA UDI
Class IIActive
Et Fixture Pick-Up Impression Coping ETFPI4515SN
FDA UDI
Class IActive
Ek Angled Abutment_a EKAA6020ATH
FDA UDI
Class IIActive
ET Transfer Abutment Set ETTA6420NCWH
FDA UDI
Class IIActive
Ek Goldcast Abutment EKGA4010NTH
FDA UDI
Class IIActive
Et Pick-Up Guide Pin ETPGPR150LC
FDA UDI
Class IActive
EK Transfer Abutment EKTA6720NTH
FDA UDI
Class IIActive
ET Transfer Abutment Set ETTA4642CWH
FDA UDI
Class IIActive
HS II Fixture Wide RBM Pre-Mounted AHS2W5010R20
FDA UDI
Class IIActive
Ek Angled Abutment(n) EKAA6020NTH
FDA UDI
Class IIActive
ET Bite Impression Coping Hex ETBICM4620H
FDA UDI
Class IActive
ET Transfer Abutment ETTA5047SNW
FDA UDI
Class IIActive
ET Angled Abutment Set ETAA4520BCWH
FDA UDI
Class IIActive
Et Fixture Pick-Up Impression Coping ETPIS4511CA
FDA UDI
Class IActive
Et Rigid Protect Cap ETRPC6007S
FDA UDI
Class IActive
ET Rigid Burn-out Cylinder ETRBC50SB
FDA UDI
Class IActive
EK Healing Abutment EKHA406
FDA UDI
Class IIActive
ET Angled Abutment_A With EG Screw ETAGA432MAW
FDA UDI
Class IIActive
Et O-Ring Lab Analog ETOAL02C
FDA UDI
Class IActive
EK III SA Fixture Pre-Mounted AEK3S3511S
FDA UDI
Class IIActive
ET Bite Impression Coping Hex ETBICR4551H
FDA UDI
Class IActive
Em Sa Implant (narrow Ridge) EMN3011S40
FDA UDI
Class IIActive
ET Bite Impression Coping Hex ETBICM4621H
FDA UDI
Class IActive
ET IV Fixture SA Ultra-Wide Pre-Mounted AET4R7011S
FDA UDI
Class IIActive
ET Rigid Abutment ETRGA4535SP
FDA UDI
Class IIActive
ET FIXTURE PICK-UP IMPRESSION COPING Regular Hex ETFPI5020SH
FDA UDI
Class IActive
ET IV Fixture SA Ultra-Wide Pre-Mounted AET4R6011S
FDA UDI
Class IIActive
Et Fixture Transfer Impression Coping ETFTI6014SH
FDA UDI
Class IActive
EK Onefit Abutment EKCMANT
FDA UDI
Class IIActive
ET Rigid Abutment ETRGA4544SP
FDA UDI
Class IIActive
ET III Fixture NH Regular No-Mounted CET3R5013B
FDA UDI
Class IIActive
ET Transfer Abutment Set ETTA6450CWH
FDA UDI
Class IIActive
Ek Angled Abutment(n) EKAA4520NTH
FDA UDI
Class IIActive
Ek Rigid Abutment EKRA4751P
FDA UDI
Class IIActive
Et Fixture Transfer Impression Coping ETTIS4514NC
FDA UDI
Class IActive
ET Convertible Abutment ETCA5030CP
FDA UDI
Class IIActive
ET Transfer Abutment Set ETTA7470NCWH
FDA UDI
Class IIActive
ET Gold Cast Abutment SET ETGA4010SCWH
FDA UDI
Class IIActive
ET Transfer Abutment ETTA4547SNW
FDA UDI
Class IIActive
ET IV NH Fixture Pre-Mounted AET4R4510B
FDA UDI
Class IIActive
Esthetic-low Pick-Up Impression Coping ETMSR200
FDA UDI
Class IActive
Et Pick-Up Guide Pin ETPGPM100LC
FDA UDI
Class IActive
ET Convertible Protect Cap ETCHC500CWH
FDA UDI
Class IActive
ET Multi Angled Abutment ETMA430SHW
FDA UDI
Class IIActive
ET Rigid Abutment ETRGA4534MP
FDA UDI
Class IIActive
ET Bite Impression Coping Hex ETBICR4561H
FDA UDI
Class IActive
ET III Fixture SA Regular [ Implant Only] ET3R5007S
FDA UDI
Class IIActive
Ek Np-Cast Abutment EKNA4010NTH
FDA UDI
Class IIActive
Esthetic-low Plastic Cylinder ETMEPR100TH
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