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BIO CONCEPT CO., LTD.

China · Changzhou

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Russia — 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

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 3Class II 2Class III 0

plus 6 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

4active device licences

Class II 3Class III 1

11 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 1IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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 States6 registration records, 3 510(k), 0 PMA, 26 excluded

Brazil0 confirmed, 10 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada4 confirmed, 6 excluded

Manufacturer names merged into this page: BIO CONCEPT CO., LTD.

FDA 510(k) clearances by year

12015 · K150388

12020 · K192274

12022 · K212364

FDA listed device types

Drill, Dental, Intraoral 1Fixture Mount Kit 1Accessories, Implant, Dental, Endosseous 1Implant, Endosseous, Root-Form 1Abutment, Implant, Dental, Endosseous 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K212364	BLT Dental Implant System	2022-08-10
US	K192274	BV Dental Implant System	2020-06-18
US	K150388	Dental Implant System	2015-11-12
CA	91591	BIOCONCEPT DENTAL IMPLANT SYSTEM	Class III
CA	96412	BIOCONCEPT IMPLANT TOOLS-BURS	Class II
CA	96413	BIOCONCEPT IMPLANT TOOLS-TAPS	Class II

BIO CONCEPT CO., LTD.

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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