Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007135442

FEI Number

3007135442

Entity Name

HIOSSEN INC.

City/State/Country

Fairless Hills, PA, US

Establishment Address

85 BEN FAIRLESS DR, Fairless Hills, PA 19030, 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

K151542

PMA Number

N/A

All Registered Proprietary Names

ET Ziocera Angled Abutments ET Gold Cast Abutments EM Provisional EK D3.3 and Ultra Wide Dental Implants ETII SA FIXTURE SYSTEM ET Freeform ST Abutments ET Quick Temporary Abutments ET Multi Abutments ET Rigid Abutments ET Ziocera Abutments ET SMARTFit Abutment Bite Impression Coping Driver 3D LAB ANALOG ET Fixture Lab Analog ONE GUIDE SURGICAL TEMPLATE ET Fixture Transfer Impression Coping Hiossen Ti Abutment Screw ET Rigid Burn-out Cylinder Esthetic Low Pick-up Impression Coping ET Bite Index Esthetic Low Transfer Impression Coping Hiossen EbonyGold Abutment Screw ET Pick-up Guide Pin ET Fixture Pick-up Impression Coping Esthetic Low Lab Analog Fixture Lab Analog ET Digital Lab Analog ET Multi Digital Lab Analog ET Scan Post - Cerec Laboratory Waxing Screw Esthetic Low Polishing Protector Esthetic Low Pick-up Impression Coping Guide Pin ET Digital Lab Analog Screw Bushing Plate EK Scanbody EK Bite Impression Coping ET Scan Body EK Lab Analog EK Digital Lab Analog Convertible Pick-Up Guide Pin Convertible Transfer Impression Coping Convertible Lab Analog ET Bite Impression Coping Multi Scan Body Rigid Lab Analog Convertible Pick-Up Impression Coping O-ring Lab Analog EK Transfer Impression Coping EK Pick Up Impression Coping Stackable Guide ET Rigid Impression Coping Convertible Polishing Protector Fixture Pick-up Impression Coping EK Dental Implants and Abutments ET Esthetic Low Plastic Cylinder ET III Nano-HA Fixture System ET III Fixture Regular NH ET III Fixture Mini NH ET Transfer Abutments ET Combination Angled Cylinder ET Multi-NP Cast Cylinder ET Convertible Angled Cylinder ET Temporary Abutments ET Stud Abutments ET Esthetic Low Temporary Cylinder ET Multi-Angled Abutments ET Angled Abutments HIOSSEN Pre-milled Abutment HIOSSEN IMPLANT SYSTEM ET III Fixture Mini SA ET III Fixture Regular SA EK Digital Abutments ET Esthetic Low Gold Cylinder ET NP-Cast Abutments EK Multi Angled 30 Degree Abutment ET Multi Angled Abutment A-Graft

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	2020-01-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2020-01-15
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2024-09-16
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-08-06
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-01-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-08-06
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2011-05-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-01-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-01-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2020-01-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-07-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-10-24
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-01-16
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-11-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2014-11-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-05-30
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-01-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2026-01-30
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2026-01-30
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-05-01
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2016-08-30

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
3017450159	HIOSSEN, INC.	Morrisville, 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
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14

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-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007135442. Last updated year: 2026. Please use registration number 3007135442 when referencing this establishment in official correspondence.