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HIOSSEN, INC.

USA · Fairless Hills

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

11listed device types

Class I 4Class II 7Class III 0

plus 33 registration records and 26 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class III 1

14 including historic records

TWTaiwanTFDA

4valid device licences

Class III 4

SGSingaporeHSA SMDR

3device registrations

CLASS B 1CLASS C 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

3active ARTG entries

IIb 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 2b 2

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States33 registration records, 26 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: HIOSSEN INC. · HIOSSEN, INC. · Hiossen, Inc.

FDA 510(k) clearances by year

22009

22010

12011

12012

32013

12014

32016

12017

22018

32019

12022

12023

22024

12025

22026

FDA listed device types

showing 8 of 11

Handpiece, Rotary Bone Cutting 1Bone Grafting Material, Animal Source 1Resin, Denture, Relining, Repairing, Rebasing 1Abutment, Implant, Dental, Endosseous 1Material, Tooth Shade, Resin 1Powder, Porcelain 1Implant, Endosseous, Root-Form 1Positioner, Tooth, Preformed 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253372	ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments	2026-05-14
US	K251427	EK MULTI ANGLED 30 ABUTMENT	2026-01-29
US	K241003	HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)	2025-01-08
CA	92917	SMARTFIT ABUTMENT	Class III

HIOSSEN, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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