HomeTaiwanBonart Co., Ltd.

Bonart Co., Ltd.

Taiwan · Keelung
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Australia, Israel, 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
6listed device types
Class I 2Class II 4Class III 0
plus 14 registration records and 14 510(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
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIa 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 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 States14 registration records, 14 510(k), 0 PMA
Manufacturer names merged into this page: BONART CO. LTD.

Company information

Country
Taiwan
City
Keelung

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

32000
12003
12005
12006
22007
32008
12010
12016
12017

FDA listed device types

Scaler, Ultrasonic 1Unit, Electrosurgical, And Accessories, Dental 1Drill, Bone, Powered 1Activator, Ultraviolet, For Polymerization 1Controller, Foot, Handpiece And Cord 1Handpiece, Contra- And Right-Angle Attachment, Dental 1

Registration details (sample)

MarketIdentifierNameClass / date
USK162856Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)2017-07-18
USK152125Oral Surgery System and Accessories2016-08-15
USK100785BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES2010-12-03

Similar companies

Abletech Orthopedics Corporation
Taiwan · markets 3
Aero Pro Co., Ltd.
Taiwan · markets 2
AiQ Smart Clothing Inc.
Taiwan · markets 0
Anest Iwata Sparmax Co., Ltd.
Taiwan · markets 3
ANGELINE GROUP LTD
Taiwan · markets 1
Apex Biotechnology Corporation
Taiwan · markets 6
Is this your company? Claim the page, add information or report a data error.Claim / report an error →