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Keystone Dental, Inc.

USA · Irvine

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Taiwan — 3 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

12listed device types

Class I 7Class II 5Class III 0

plus 55 registration records and 12 510(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

21active device licences

Class II 6Class III 15

64 including historic records

TWTaiwanTFDA

13valid device licences

Class I 5Class II 4Class III 4

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 States55 registration records, 12 510(k), 0 PMA, 11 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada21 confirmed, 1 excluded

Manufacturer names merged into this page: Keystone Dental Inc. · MYCONE DENTAL SUPPLY CO. INC. DBA KEYSTONE INDUSTRIES · MYCONE DENTAL SUPPLY CO INC., T/A KEYSTONE INDUSTRIES · KEYSTONE DENTAL · KEYSTONE DENTAL, INC.

FDA 510(k) clearances by year

11998

22007

12009

12010

12016

12018

12020

12021

12022

12023

12024

FDA listed device types

showing 8 of 12

Bone Grafting Material, Human Source 1Teeth, Porcelain 1Abutment, Implant, Dental, Endosseous 1Bone Grafting Material, Synthetic 1Implant, Endosseous, Root-Form 1Bur, Dental 1Instruments, Dental Hand 1Dental Implant Surgical Tray 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240966	Prima Plus Conical Implant System	2024-07-09
US	K223814	Genesis ACTIVE Implant System	2023-05-25
US	K221381	KDG Abutments	2022-08-10
CA	5153	B-CROWN	Class II
CA	63208	SYRIJET NEEDLE FREE INJECTORS	Class II
CA	8219	VERSA-LOCK	Class II

Keystone Dental, 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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