Home›Japan›YAMAHACHI DENTAL MFG., Co.

YAMAHACHI DENTAL MFG., Co.

Japan · Gamagori City

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, 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

7listed device types

Class I 3Class II 4Class III 0

plus 11 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

17registered devices

Class I 1Class II 16

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

7 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

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 States11 registration records, 3 510(k), 0 PMA, 3 excluded

Brazil17 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: YAMAHACHI DENTAL MFG. CO. · YAMAHACHI DENTAL MFG, CO · YAMAHACHI DENTAL MFG CO · YAMAHACHI DENTAL MFG., CO.

FDA 510(k) clearances by year

12018 · K172683

12024 · K233859

12026 · K254091

FDA listed device types

Accessories, Implant, Dental, Endosseous 1Material, Impression Tray, Resin 1Wax, Dental, Intraoral 1Crown And Bridge, Temporary, Resin 1Denture, Plastic, Teeth 1Coating, Filling Material, Resin 1Resin, Denture, Relining, Repairing, Rebasing 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254091	GLOSSY COAT (15ML)	2026-04-06
US	K233859	BASIS FLOW II	2024-03-05
US	K172683	Yamahachi Pink CAD/CAM Disk	2018-01-16
BR	10370549004	DENTES ARTIFICIAIS NEW SOLUUT	Class II
BR	10370540049	FX TRI	Class II
BR	10370540050	REFINE BRIGHT	Class II
CA	86990	DENTAL ATTACHMENT	Class II

YAMAHACHI DENTAL MFG., Co.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies