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Home›USA›DENTSPLY LLC TRADING AS "DENTSPLY PROFESSIONAL"

DENTSPLY LLC TRADING AS "DENTSPLY PROFESSIONAL"

USA · Des Plaines
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in Brazil, Saudi Arabia, Canada — 3 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
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
21registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
37active device licences
Class II 33Class III 4
95 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
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 States0 registration records, 0 510(k), 0 PMA, 25 excluded
Brazil1 confirmed, 14 excluded
Saudi Arabia21 confirmed, 16 excluded
Canada37 confirmed, 22 excluded
Manufacturer names merged into this page: DENTSPLY LLC PROFESSIONAL DIVISION ALSO DBA DENTSPLY PROFESSIONAL · DENTSPLY LLC PROFESSIONAL DIVISION TRADING AS SULTAN HEALTHCARE · DENTSPLY LLC TRADING AS "DENTSPLY PROFESSIONAL" · DENTSPLY LLC PROFESSIONAL DIVISION ALSO DBA DENTSPLY PHARMACEUTICAL · DENTSPLY PROFESSIONAL · Dentsply Professional
Same-named companies — This database also contains companies with near-identical names: DENTSPLY PROFESSIONAL. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Des Plaines

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.

Registration details (sample)

MarketIdentifierNameClass / date
BR80196880295PONTAS CAVITRONClass II
SAME0000012365SFDAA00001Nupro Disposable Dual Arch Fluoride Trays—
SAME0000004764SFDAA00001Nupro Dual Arch Fluoride Tray—
CA783ENDOSONIC INSERTSClass II
CA2924CAVITRON PROPHY JET AIR POLISHING PROPHYLAXIS UNITClass II
CA3209DELTON FS+ FLOWABLE PIT & FISSURE SEALANT WITH FLUORIDEClass III

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