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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 47 of 65
DeviceModel / ReferenceRegistriesClassStatus
EK Transfer Abutment EKTA7630TH
FDA UDI
Class IIActive
EK Transfer Abutment EKTA7430TH
FDA UDI
Class IIActive
Ek Transfer Abutment EKTA6610NTH
FDA UDI
Class IIActive
Bite Impression Coping ETBICR5630
FDA UDI
Class IActive
ET Bite Impression Coping Hex ETBICR4451H
FDA UDI
Class IActive
ET IV NH Ultra-Wide Fixture Pre-Mounted AET4R6011B
FDA UDI
Class IIActive
ET Transfer Abutment ETTA5077SHW
FDA UDI
Class IIActive
Et Rigid Lab Analog ETRLA4005
FDA UDI
Class IActive
Et Freeform St Abutment Set ETFAM4030CWH
FDA UDI
Class IIActive
ET Rigid Abutment SET ETRAS4751CP
FDA UDI
Class IIActive
ET Transfer Abutment ETTA4565SHW
FDA UDI
Class IIActive
Et Stud Abutment Set ETSAO355S
FDA UDI
Class IIActive
HS II Fixture Regular RBM Pre-Mounted AHS2R4010R28
FDA UDI
Class IIActive
Et Pick-Up Guide Pin ETPGPR200LC
FDA UDI
Class IActive
ET Gold Cast Abutment SET ETGA4530BCWH
FDA UDI
Class IIActive
ETIII SA (Ø3.2mm) [ Implant Only ] ET3M3013S
FDA UDI
Class IIActive
Et Bite Index ETBIS5506SC
FDA UDI
Class IActive
ET Rigid Abutment ETRGA4035SP
FDA UDI
Class IIActive
ET Rigid Abutment SET ETRA5650CP
FDA UDI
Class IIActive
EK III SA Fixture No Mount CEK3S7013S
FDA UDI
Class IIActive
ET Rigid Abutment SET ETRA6720CP
FDA UDI
Class IIActive
Et Freeform St Abutment Set ETFA4015CWH
FDA UDI
Class IIActive
Et Fixture Pick-Up Impression Coping ETFPI4511SN
FDA UDI
Class IActive
HG II Fixture RBM Regular No Mount CHG2S5013R
FDA UDI
Class IIActive
Et Rigid Impression Coping ETRIC570SC
FDA UDI
Class IActive
Et Pick-Up Guide Pin ETFPG05SL
FDA UDI
Class IActive
Et Fixture Pick-Up Impression Coping ETFPI4515MH
FDA UDI
Class IActive
ET Healing Abutment ETHLA5004R
FDA UDI
Class IIActive
ET Pre-milled Abutment ETPMA10ARMNW
FDA UDI
Class IIActive
Et Goldcast Abutment ETGCA401MNW
FDA UDI
Class IIActive
ET Transfer Abutment ETTA4517MHW
FDA UDI
Class IIActive
EK Transfer Abutment EKTA6430NTH
FDA UDI
Class IIActive
ET Rigid Abutment SET ETRA4441CP
FDA UDI
Class IIActive
ET Rigid Abutment SET ETRAS4411CP
FDA UDI
Class IIActive
EK Transfer Abutment EKTA6650NTH
FDA UDI
Class IIActive
ET Transfer Abutment ETTA7054SHW
FDA UDI
Class IIActive
Et Freeform St Abutment ETFSAS501SNW
FDA UDI
Class IIActive
Et Fixture Transfer Impression Coping ETFTI4511MN
FDA UDI
Class IActive
EK III NH Fixture No Mount CEK3S5511B
FDA UDI
Class IIActive
EK Healing Abutment EKHA606
FDA UDI
Class IIActive
ET Rigid Abutment ETRGA4515SP
FDA UDI
Class IIActive
EK III NH Fixture No Mount CEK3S3008B
FDA UDI
Class IIActive
EK Hybrid Zirconia Abutment EKHZ4063CHT
FDA UDI
Class IIActive
Et Fixture Transfer Impression Coping ETTIS6014NC
FDA UDI
Class IActive
ET II Fixture SA Regular No-Mounted CET2R4007S
FDA UDI
Class IIActive
ET Transfer Abutment Set ETTA5720CWH
FDA UDI
Class IIActive
ET Rigid Abutment SET ETRA4431CP
FDA UDI
Class IIActive
EK III SA Fixture Pre-Mounted AEK3S7007S
FDA UDI
Class IIActive
ET III Fixture NH Regular No-Mounted CET3R5006B
FDA UDI
Class IIActive
ET Rigid Abutment ETRGA4025SP
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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Authorities

Not available yet.

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