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DENTCA, INC.

USA · Irvine

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, South Korea, Australia — 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

5listed device types

Class I 1Class II 4Class III 0

plus 6 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

5 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

3active ARTG entries

IIa 3

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 States6 registration records, 6 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: DENTCA, INC.

FDA 510(k) clearances by year

12015 · K143033

22017 · K172398

12020 · K192806

12022 · K220042

12026 · K261474

FDA listed device types

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Crown And Bridge, Temporary, Resin 1Additively Manufactured, Preformed, Resin Denture Tooth 1Resin, Denture, Relining, Repairing, Rebasing 1Tray, Impression, Preformed 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261474	DENTCA Tru Flexible	2026-07-01
US	K220042	Dentca Base Premium, Dentca Base Hi-Impact	2022-11-17
US	K192806	DENTCA Crown and Bridge	2020-02-05
BR	10166849014	LÍQUIDO FOTOPOLIMERIZÁVEL PARA IMPRESSÃO EM 3D	Class II

DENTCA, INC.

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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