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DENTAMERICA

USA · City Of Industry

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Taiwan, Australia, Israel — 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

23listed device types

Class I 18Class II 5Class III 0

plus 23 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States23 registration records, 4 510(k), 0 PMA

Manufacturer names merged into this page: DENTAMERICA

FDA 510(k) clearances by year

21996 · K954820

12006 · K060640

12010 · K092833

FDA listed device types

showing 8 of 23

Light, Fiber Optic, Dental 1Retainer, Matrix 1Illuminator, Radiographic-Film 1Bur, Dental 1Handpiece, Direct Drive, Ac-Powered 1Mirror, Mouth 1Unit, Operative Dental, Accessories 1Light, Operating, Dental 1

Market	Identifier	Name	Class / date
US	K092833	ENDOMAX CORDLESS ENDODONTIC HANDPIECE	2010-01-07
US	K060640	DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM	2006-04-24
US	K954820	SCALEX 800	1996-01-18

DENTAMERICA

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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