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Pac-Dent International, Inc.

USA · Brea

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia — 5 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

84listed device types

Class I 68Class II 14Class III 0unclassified 2

plus 120 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 2Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

0active device licences

10 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

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 States120 registration records, 19 510(k), 0 PMA, 5 excluded

Brazil3 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: PAC-DENT INC. · Suzhou Pac-Dent Technology Co., Ltd · SUZHOU PAC-DENT TECHNOLOGY CO. LTD. · PAC-DENT INTERNATIONAL, INC. · Pac-Dent, Inc

Same-named companies — This database also contains companies with near-identical names: Pac-Dent, Inc., Pac-Dent International (Suzhou), Ltd., Suzhou Pac-Dent Technology Co., Ltd. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12003

12004

12013

12014

32015

32016

12017

12020

52021

22022

FDA listed device types

showing 8 of 84

Frame, Rubber Dam 1Handpiece, Air-Powered, Dental 1Evacuator, Oral Cavity 1Positioner, Tooth, Preformed 1Syringe, Restorative And Impression Material 1Pick, Massaging 1Accessories, Implant, Dental, Endosseous 1Material, Impression Tray, Resin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K202674	Medidenta High Speed Handpieces	2022-12-12
US	K202920	OptiComp	2022-05-25
US	K202831	The iMask Child's Face Mask	2021-08-26
BR	10223060034	TAÇA PARA PROFILAXIA - PAC-DENT	Class I
BR	10223060036	ESCOVA LISA PAC-DENT	Class II
BR	10223060035	PONTA DE MISTURA HP - PAC-DENT	Class I
SA	ME0000009293SFDAA00002	PAC-DENT / CARBIDE BURS	—
SA	ME0000022178SFDAA00002	Carbide Burs	—

Pac-Dent International, 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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