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DENTAL HI TEC

France · Mazieres En Mauges Maine-Et-Loire

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel — 6 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

17listed device types

Class I 9Class II 8Class III 0

plus 17 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

2 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class II 3

11 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States17 registration records, 3 510(k), 0 PMA, 44 excluded

Brazil0 confirmed, 13 excluded

Saudi Arabia0 confirmed, 6 excluded

Canada3 confirmed, 2 excluded

Manufacturer names merged into this page: DENTAL HI TEC · Tosoh Hi-Tec, Inc. · XIAMEN EVERYOUNG OPTICAL HI-TEC CO., LTD. · HI TEC IMPLANTS, LTD. · HI-TEC MEDICAL GMBH · HI TEC IMPLANTS LTD.

FDA 510(k) clearances by year

11994 · K941575

11995 · K930013

11997 · K955477

FDA listed device types

showing 8 of 17

Hemoglobin A1c Test System 1Injector, Jet, Mechanical-Powered 1Abutment, Implant, Dental, Endosseous 1Calibrator, Primary 1Syringe, Cartridge 1Implant, Endosseous, Root-Form 1Hemoglobin A2 Quantitation 1Assay, Glycosylated Hemoglobin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K955477	HI-TEC CO2 INSUFFLATOR TYPE 1300	1997-08-06
US	K930013	CO2 INSUFFLATOR 1100	1995-04-14
US	K941575	SMOOTH FIT	1994-11-17
CA	67679	ASPIRATORS - ENDOSCOPIC IRRIGATION	Class II
CA	67681	INSUFFLATORS/ HYSTEROSCOPIC	Class II
CA	67682	IRRIGATION/ DISTENSION SYSTEMS - ARTHROSCOPIC	Class II

DENTAL HI TEC

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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