Hiossen, Inc.

FDA Device Registration & Listing · Buena Park, CA, US · Registration 3031162123

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3031162123
FEI Number
3031162123
Entity Name
Hiossen, Inc.
City/State/Country
Buena Park, CA, US
Establishment Address
6940 Beach Blvd, Building D Unit D-709, Buena Park, CA 90621, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Hiossen Inc. (Owner Number: 10026425)
Owner / Operator Contact Address
85 Ben Fairless Dr., Fairless Hills, PA 19030, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K123627
PMA Number
N/A

All Registered Proprietary Names

EK Digital Abutments ET SMARTFit Abutment

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-05-30
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-08-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hiossen Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010185635 HIOSSEN INC. Norwood, NJ, US
3017450159 HIOSSEN, INC. Morrisville, PA, US
3007135442 HIOSSEN INC. Fairless Hills, PA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K211871 Faico Medical, LLC FAICO Dental Implant System and CAD/CAM Abutments 2021-11-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2018 Implant Direct Sybron Manufacturing, LLC 2
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031162123. Last updated year: 2026. Please use registration number 3031162123 when referencing this establishment in official correspondence.
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