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Dental Research Corp.

USA · Tucker

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Israel — 4 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

24listed device types

Class I 14Class II 10Class III 0

plus 29 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 2Class II 3

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States29 registration records, 15 510(k), 0 PMA, 381 excluded

Brazil5 confirmed, 29 excluded

Saudi Arabia0 confirmed, 11 excluded

Canada0 confirmed, 41 excluded

Manufacturer names merged into this page: Park Dental Research Corp · PARK DENTAL RESEARCH CORP. · PARK DENTAL RESEARCH CORP · DENTAL IMPLANT RESEARCH INSTITUTE LTDA ME

FDA 510(k) clearances by year

51980

11985

11986

11987

12001

12010

12012

12018

12019

12024

12025

FDA listed device types

showing 8 of 24

Bone Grafting Material, Animal Source 1Barrier, Animal Source, Intraoral 1Resin, Denture, Relining, Repairing, Rebasing 1Abutment, Implant, Dental, Endosseous 1Scaler, Ultrasonic 1Bone Grafting Material, Synthetic 1Orthodontic Software 1Aligner, Sequential 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252976	Park Dental Nylon MAD	2025-12-18
US	K233935	DigiLine Direct Print Aligner System	2024-04-05
US	K180648	Park Dental Research Aligners	2019-01-08
BR	81103659001	DigiLine Direct Print Resin	Class II
BR	81492240004	Transfer em titanio	Class I
BR	81492240001	Chave em aço inoxidável	Class I

Dental Research Corp.

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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