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Biomaterials Korea, Inc.

Korea, Republic · Hanam-Si Gyeonggi

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Taiwan, Singapore — 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

17listed device types

Class I 15Class II 2Class III 0

plus 20 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

5valid device licences

Class I 3Class II 1Class III 1

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

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 States20 registration records, 5 510(k), 0 PMA, 32 excluded

Brazil1 confirmed, 4 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: BIOMATERIALS KOREA INC.

FDA 510(k) clearances by year

12007 · K063495

22011 · K110926

12018 · K173623

12023 · K222245

FDA listed device types

showing 8 of 17

Spring, Orthodontic 1Bur, Dental 1Positioner, Tooth, Preformed 1Clamp, Wire, Orthodontic 1Accessories, Implant, Dental, Endosseous 1Forceps, Rongeur, Surgical 1Handle, Instrument, Dental 1Instrument, Cutting, Operative 1

Market	Identifier	Name	Class / date
US	K222245	ACR Screw System	2023-08-21
US	K173623	Anchor plate	2018-08-30
US	K110926	BONE PLATE; BONE SCREW	2011-12-08
BR	80432070003	EXPANSOR PALATAL - MSE	Class II

Biomaterials Korea, 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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