HIOSSEN INC.

FDA Device Registration & Listing · Norwood, NJ, US · Registration 3010185635

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
3010185635
FEI Number
3010185635
Entity Name
HIOSSEN INC.
City/State/Country
Norwood, NJ, US
Establishment Address
50 Maple Street, Norwood, NJ 07648, US
Establishment Type(s)
Repack or Relabel 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
Y
Expiration Date (Year)
2026
510(k) Number
K173905
PMA Number
N/A

All Registered Proprietary Names

SM3

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2019-05-09
KMW Handpiece, Rotary Bone Cutting Dental Class 2 872.4120 2019-05-09
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2019-05-09

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
3031162123 Hiossen, Inc. Buena Park, CA, 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
K040153 Indigenous Peoples Technology and Education Center I-TEC PORTABLE DENTAL OPERATORY 2004-05-21

Similar Registrations

Registration Number Establishment Name Location
3014683120 JMU DENTAL, INC Fullerton, CA, US
2520265 DENTALEZ, INC., STARDENTAL DIVISION Lancaster, PA, US
3009768364 Foshan CICADA Dental Instrument Co., Ltd. Foshan Guangdong, CN
9611253 NAKANISHI INC. Kanuma Tochigi, JP
1054713 TOYO MEDICAL CO. Doral, FL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010185635. Last updated year: 2026. Please use registration number 3010185635 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.