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Home›Taiwan›ENLIGHTEN MATERIALS CO., LTD.

ENLIGHTEN MATERIALS CO., LTD.

Taiwan · Taipei City
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
4listed device types
Class I 2Class II 2Class III 0
plus 4 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class I 1Class II 4
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
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 States4 registration records, 2 510(k), 0 PMA
Brazil5 confirmed, 0 excluded
Manufacturer names merged into this page: ENLIGHTEN MATERIALS CO., LTD. · ENLIGHTEN MATERIALS CO LTD.

Company information

Country
Taiwan
City
Taipei City

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

22020 · K191591

FDA listed device types

Accessories, Implant, Dental, Endosseous 1Material, Impression Tray, Resin 1Crown And Bridge, Temporary, Resin 1Resin, Denture, Relining, Repairing, Rebasing 1

Registration details (sample)

MarketIdentifierNameClass / date
USK191591BB Base 3D printing resin for denture base2020-08-18
USK191590AA temp temporary restoration 3D printing photoreactive resin2020-05-05
BR10352040049Resinas para impressão 3dClass II
BR10352040045resinas para impressão 3dClass I
BR10352040046RESINAS PARA IMPRESSÃO 3DClass II

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