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DENTONICS, INC.

USA · Monroe

✓ Record-verifiedregistrations found in 5 markets

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

12listed device types

Class I 3Class II 9Class III 0

plus 25 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 1IIa 5

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 States25 registration records, 0 510(k), 0 PMA

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: DENTONICS, INC. · Dentonics,Inc. · DENTONICS,INC

FDA listed device types

showing 8 of 12

Sealant, Pit And Fissure, And Conditioner 1Cement, Dental 1Adhesive, Bracket And Tooth Conditioner, Resin 1Material, Tooth Shade, Resin 1Material, Impression 1Varnish, Cavity 1Crown And Bridge, Temporary, Resin 1Resin, Root Canal Filling 1

Market	Identifier	Name	Class / date
SA	ME0000005621SFDAA00002	SYNERGY Dual Component Tooth Whitening System	—
SA	ME0000001394SFDAA00006	VIVACITY Tooth Whitener	—

DENTONICS, INC.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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