HomeUSADharma Research, Inc.

Dharma Research, Inc.

USA · Miami
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Israel, Russia — 5 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
11listed device types
Class I 6Class II 5Class III 0
plus 11 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
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
3active registrations
Class 2a 3
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 States11 registration records, 1 510(k), 0 PMA, 1 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: Dharma Research/Medeco International · Dharma Research Inc.
Same-named companies — This database also contains companies with near-identical names: Dharma Research/Medeco International. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Miami

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

12015 · K150696

FDA listed device types

showing 8 of 11
Sealant, Pit And Fissure, And Conditioner 1Varnish, Cavity 1Material, Tooth Shade, Resin 1Material, Impression 1Agent, Tooth Bonding, Resin 1Syringe, Periodontic, Endodontic, Irrigating 1Tray, Fluoride, Disposable 1Dam, Rubber 1

Registration details (sample)

MarketIdentifierNameClass / date
USK150696Jade 37% Phosphoric Acid Etchant Gel2015-06-23
SAME0000000352SFDAA00002Qartz Prophylaxis Paste

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