HomeChinaDenjoy Dental Co., Ltd.

Denjoy Dental Co., Ltd.

China · Changsha City Hunan
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Singapore, Israel, Russia — 6 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
15listed device types
Class I 13Class II 2Class III 0
plus 14 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
5registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
4valid device licences
Class I 4
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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, 1 510(k), 0 PMA
Saudi Arabia5 confirmed, 0 excluded
Manufacturer names merged into this page: DENJOY DENTAL CO., LTD · Denjoy Dental Co LTD · Denjoy Dental Co., LTD

Company information

Country
China
City
Changsha City Hunan

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

12025 · K242317

FDA listed device types

showing 8 of 15
Camera, Cine, Endoscopic, With Audio 1Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment 1Instruments, Dental Hand 1Handpiece, Direct Drive, Ac-Powered 1Plugger, Root Canal, Endodontic 1Accessory, Surgical Apparel 1Unit, Operative Dental, Accessories 1Accessories, Retractor, Dental 1

Registration details (sample)

MarketIdentifierNameClass / date
USK242317Integrated Endo System (Meet Endo-II)2025-02-13
SAME0000005582SFDAA00002Denjoy ® Obturation System
SAME0000003806SFDAA00001Denjoy ® Endo File

Similar companies

Acoresmed Co., Ltd.
China · markets 1
Aimagine Care Technology Co., Ltd.
China · markets 2
Allmed Medical Products Co. Ltd.
China · markets 12
ALTON(shanghai)medical Instruments Co.,Ltd
China · markets 12
Ambulanc (Shenzhen) Tech. Co. Ltd.
China · markets 10
Andon Health Co., Ltd.
China · markets 10
Is this your company? Claim the page, add information or report a data error.Claim / report an error →