HomeIndiaPREVEST DENPRO LIMITED

PREVEST DENPRO LIMITED

India · Jammu
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia, Israel, Russia — 7 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
15listed device types
Class I 8Class II 7Class III 0
plus 15 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
13registered devices
Class II 13
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class I 2IIa 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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 States15 registration records, 7 510(k), 0 PMA
Brazil13 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: PREVEST DENPRO LIMITED · Prevest DenPro Limited

Company information

Country
India
City
Jammu

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

12021 · K200555
32022 · K213244
12023 · K231696
22024 · K233273

FDA listed device types

showing 8 of 15
Plate, Base, Shellac 1Wax, Dental, Intraoral 1Plaque Disclosing Agent 1File, Pulp Canal, Endodontic 1Accessories, Implant, Dental, Endosseous 1Cleanser, Denture, Over The Counter 1Agent, Polishing, Abrasive, Oral Cavity 1Zinc Oxide Eugenol 1

Registration details (sample)

MarketIdentifierNameClass / date
USK233273C&B Ceramic; C&B Permanent; C&B Interim2024-11-27
USK231263Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT2024-01-05
USK231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal2023-08-11
BR81504799147Magma NTClass II
BR81504799148Fusion FloClass II
BR81504799149ORATEMP C&BClass II
SAME0000004275SFDAA00075Hemostal Gel

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