HomeUSAKeystone Industries

Keystone Industries

USA · Myerstown
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Australia — 7 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
53listed device types
Class I 42Class II 10Class III 0unclassified 1
plus 108 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
7registered devices
Class II 7
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
10registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
15active device licences
Class II 14Class III 1
54 including historic records
TWTaiwanTFDA
10valid device licences
Class I 9Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
18active ARTG entries
Class I 14IIa 4
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 States108 registration records, 6 510(k), 0 PMA, 11 excluded
Brazil7 confirmed, 0 excluded
Saudi Arabia10 confirmed, 0 excluded
Canada15 confirmed, 2 excluded
Manufacturer names merged into this page: Keystone Industries - Gibbstown · Keystone Industries · Keystone Industries - Delran · KEYSTONE INDUSTRIES · MYCONE DENTAL SUPPLY CO. INC. DBA KEYSTONE INDUSTRIES · MYCONE DENTAL SUPPLY CO INC., T/A KEYSTONE INDUSTRIES

Company information

Country
USA
City
Myerstown

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

12016 · K152051
12018 · K172764
12019 · K183598
12021 · K203000
12024 · K241089
12025 · K250489

FDA listed device types

showing 8 of 53
Sealant, Pit And Fissure, And Conditioner 1Cement, Dental 1Resin, Denture, Relining, Repairing, Rebasing 1Wrap, Sterilization 1Mask, Surgical 1Varnish, Cavity 1Material, Impression 1Powder, Porcelain 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250489FP3D2025-05-20
USK241089KeyPrint KeyDenture Base2024-10-24
USK203000KeyPrint KeySplint Hard2021-04-09
BR80033549018Resina de Impressão 3D para confecção de Protetores Bucais KeyGuardClass II
BR80033549019Resina acrílica de Alto Impacto Diamond D Vertida - HIPAClass II
BR80033549020DISCOS DE ACRÍLICO PARA PRÓTESE DENTÁRIA DE ALTO IMPACTO KEYMILL™ DIAMClass II
SAME0000008626SFDAA00037PREHMA DENTAL DAMS
SAME0000005861SFDAA00004SOFT EVA
CA10166GLAZEClass II
CA61290DUZ-ALLClass II
CA61294LIGHT LINERClass II

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