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DENTSPLY LLC ALSO DBA DENTSPLY CAULK

USA · Milford

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

2510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class I 2Class II 8

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

66registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

16active device licences

Class II 3Class III 13

56 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, 2 510(k), 0 PMA, 1 excluded

Brazil10 confirmed, 0 excluded

Saudi Arabia66 confirmed, 0 excluded

Canada16 confirmed, 0 excluded

Manufacturer names merged into this page: DENTSPLY LLC ALSO DBA DENTSPLY CAULK · DENTSPLY CAULK · DENTSPLY Caulk · Dentsply LLC also trading as DENTSPLY Caulk · Dentsply Caulk · Dentsply LLC, also trading as DENTSPLY Caulk

Same-named companies — This database also contains companies with near-identical names: Caulk Co., Div. Dentsply, Dentsply LLC, also trading as DENTSPLY Caulk, DENTSPLY CAULK. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K812277	PRISMA-FIL COMPULES	1981-09-08
US	K782080	VENEER SYSTEM, MOSTIQUE LAMINATE	1979-01-26
BR	80196880206	SILICONES DE ADICAO AQUASIL	Class I
BR	80196889047	CALIBRA VENEER	Class II
BR	80196889052	SDR PLUS	Class II
SA	ME0000001657SFDAA00011	Prisma Gloss Composite Polishing Paste system	—
SA	ME0000001657SFDAA00023	Aquasil Ultra	—
CA	1227	VISCO-GEL	Class II
CA	1441	ENFORCE WITH FLUORIDE RESIN CEMENT	Class III
CA	1552	PRINCIPLE SELF-ADHESIVE COMPOMER CEMENT	Class III

DENTSPLY LLC ALSO DBA DENTSPLY CAULK

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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