HomeUSADentlight, Inc.

Dentlight, Inc.

USA · Plano
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Taiwan, Israel, Russia — 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
10listed device types
Class I 4Class II 6Class III 0
plus 9 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
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
2active registrations
Class 1 2
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 States9 registration records, 4 510(k), 0 PMA
Manufacturer names merged into this page: DENTLIGHT INC.

Company information

Country
USA
City
Plano

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

12005 · K052593
12010 · K101140
12019 · K180065
12021 · K201387

FDA listed device types

showing 8 of 10
Loupe, Diagnostic/Surgical 1Camera, Television, Surgical, With Audio 1Light, Examination, Medical, Battery Powered 1Light, Surgical Headlight 1Lamp, Infrared, Therapeutic Heating 1Activator, Ultraviolet, For Polymerization 1Detector, Ultraviolet 1Powered Laser Surgical Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
USK201387Ultrafast, Ultrafast Plus, Ultrafast Lite2021-02-26
USK180065FUSION Plus Curing Light2019-04-19
USK101140DENTLIGHT ORAL EXAM LIGHT KIT2010-07-15

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