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FDA 510(k) Applications Submitted by Hiossen, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K180527
02/28/2018
IS3
Hiossen, Inc.
K240232
01/29/2024
EK D3.3 and Ultra Wide Implants
Hiossen, Inc.
K241003
04/12/2024
HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
Hiossen, Inc.
K191201
05/06/2019
EM SA Implant System
Hiossen, Inc.
K191751
07/01/2019
EM Provisional
Hiossen, Inc.
K233389
10/02/2023
EK Digital Abutments
Hiossen, Inc.
K203360
11/16/2020
EK Implants and Abutments System
Hiossen, Inc.
K183242
11/21/2018
ET IV SA Dental Implants
Hiossen, Inc.
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