Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017450159

FEI Number

3017450159

Entity Name

HIOSSEN, INC.

City/State/Country

Morrisville, PA, US

Establishment Address

56-58A East Bridge Street, Morrisville, PA 19067, 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

Expiration Date (Year)

2026

510(k) Number

K171585

PMA Number

N/A

All Registered Proprietary Names

EK Digital Abutments Smartfit Provisional Denture Smartfit Try In Hybrid Denture ET SMARTFit Abutment Smartfit Final Hybrid Denture

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
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-03-24
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2025-03-24
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-08-06
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2025-03-24

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
3010185635	HIOSSEN INC.	Norwood, NJ, 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
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23

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.
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain

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3011587077	JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD.	Changzhou Jiangsu, CN
3012121192	DENTAL EVOLUTIONS, INC	Beverly Hills, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017450159. Last updated year: 2026. Please use registration number 3017450159 when referencing this establishment in official correspondence.