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Park Dental Research Corporation

USA · Ardmore

✓ 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

25listed device types

Class I 14Class II 11Class III 0

plus 30 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

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 States30 registration records, 8 510(k), 0 PMA, 24 excluded

Brazil1 confirmed, 3 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: Park Dental Research Corp · SOLOMON PARK RESEARCH LABORATORIES, INC. · PARK DENTAL RESEARCH CORP. · PARK DENTAL RESEARCH CORP

FDA 510(k) clearances by year

11986

11987

12010

12012

12018

12019

12024

12025

FDA listed device types

showing 8 of 25

Bone Grafting Material, Animal Source 1Barrier, Animal Source, Intraoral 1Resin, Denture, Relining, Repairing, Rebasing 1Abutment, Implant, Dental, Endosseous 1Calibrator, Multi-Analyte Mixture 1Scaler, Ultrasonic 1Bone Grafting Material, Synthetic 1Orthodontic Software 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

Park Dental Research Corporation

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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