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DENTALEZ, INC., STARDENTAL DIVISION

USA · Lancaster

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

14listed device types

Class I 13Class II 1Class 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

1active device licences

Class II 1

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

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: DENTALEZ, INC., STARDENTAL DIVISION

FDA 510(k) clearances by year

12009 · K083252

12013 · K130455

12024 · K240183

12026 · K251701

FDA listed device types

showing 8 of 14

Spreader, Pulp Canal Filling Material, Endodontic 1Curette, Periodontic 1Controller, Foot, Handpiece And Cord 1Handpiece, Air-Powered, Dental 1Handpiece, Contra- And Right-Angle Attachment, Dental 1Unit, Operative Dental 1Frame, Rubber Dam 1Plugger, Root Canal, Endodontic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251701	Star E900 Electric System	2026-01-12
US	K240183	Star E900 Handpiece Series	2024-09-19
US	K130455	430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES	2013-09-25
CA	72128	NOUVEAU CARBIDE DENTAL BURS	Class II

DENTALEZ, INC., STARDENTAL DIVISION

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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