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PARKELL, INC.

USA · Edgewood

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

29listed device types

Class I 12Class II 15Class III 0unclassified 2

plus 47 registration records and 61 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 3Class II 3

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

6active device licences

Class II 3Class III 3

43 including historic records

TWTaiwanTFDA

7valid device licences

Class I 4Class II 3

SGSingaporeHSA SMDR

3device registrations

CLASS B 2CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

4active ARTG entries

Class I 2IIa 2

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 2Class 2b 1

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 States47 registration records, 61 510(k), 0 PMA

Brazil6 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: PARKELL, INC. · PARKELL INC.

FDA 510(k) clearances by year

31996

41997

41998

21999

22000

22001

22002

22003

12004

42006

22008

12010

12012

12014

22015

12017

12018

22019

12022

12025

FDA listed device types

showing 8 of 29

Activator, Ultraviolet, For Polymerization 1Cement, Dental 1Resin, Denture, Relining, Repairing, Rebasing 1Tester, Pulp 1Alloy, Metal, Base 1Liner, Cavity, Calcium Hydroxide 1Scaler, Ultrasonic 1Material, Tooth Shade, Resin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243254	Parkell Pit and Fissure Sealant	2025-08-08
US	K210259	Parkell Self-Adhesive Cement	2022-01-20
US	K191103	Parkell Desensitizer Gel	2019-11-22
BR	10347940159	ACCUFILM	Class I
BR	80330460004	Papel carbono para articulação Accufilm II	Class I
BR	10347940194	Accufilm Fastcheck	Class I
CA	68090	TR-2 TEMPORARY CEMENT	Class II
CA	68097	FORAMATRON D10 APEX LOCATOR	Class II
CA	68098	AEROETCHER INTRA-ORAL BLASTER	Class II