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OSSTEM IMPLANT BRASIL LTDA

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

27listed device types

Class I 15Class II 12Class III 0

plus 167 registration records and 70 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

75registered devices

Class I 68Class II 7

127 including historic records

SASaudi ArabiaSFDA

25registered imported devices

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

CACanadaMDALL

4active device licences

Class II 3Class III 1

41 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States167 registration records, 70 510(k), 0 PMA, 4 excluded

Brazil75 confirmed, 1 excluded

Saudi Arabia25 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: OSSTEM IMPLANT CO., LTD. · OSSTEM IMPLANT CO.,LTD. · OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS · OSSTEM IMPLANT CO., LTD · OSSTEM IMPLANT CO. LTD · OSSTEM IMPLANT BRASIL LTDA

Same-named companies — This database also contains companies with near-identical names: OSSTEM IMPLANT CO., LTD., Osstem Implant Company., Ltd. Chair Business. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

22007

112008

22009

32010

22011

52012

42013

42014

12015

42016

72017

22018

52019

12020

32021

12022

32023

42024

22025

12026

FDA listed device types

showing 8 of 27

Curette, Surgical, Dental 1Bur, Dental 1Unit, Operative Dental 1Oral Surgery Tray 1Needle, Dental 1Syringe, Restorative And Impression Material 1Accessories, Retractor, Dental 1Chair, Dental, With Operative Unit 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251434	Healing Abutment System	2026-03-04
US	K251569	Bone Screw	2025-08-13
US	K251491	K5 Cart, K5 Mount, K5 Swing	2025-07-17
BR	82285310012	Ortho KIT	Class I
BR	80259860077	Osstem Instrumento 2	Class I
BR	80259860079	Osstem Instrumento 5	Class I
SA	ME0000013323SFDAA00002	TS Fixture Transfer Impression Coping	—
SA	ME0000013323SFDAA00003	TS Fixture Pick Up Impression Coping	—
CA	94065	DENTAL FIXTURES - US SYSTEM	Class III
CA	110921	MEMBRANE LIFTER	Class II
CA	110923	MS REMOVAL TOOL	Class II

OSSTEM IMPLANT BRASIL LTDA

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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