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Prime Dental Manufacturing , Inc.

USA · Chicago

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel, Russia — 8 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

22listed device types

Class I 12Class II 9Class III 0unclassified 1

plus 26 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

8valid device licences

Class I 1Class II 7

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 5

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 States26 registration records, 15 510(k), 0 PMA, 7 excluded

Brazil2 confirmed, 132 excluded

Saudi Arabia1 confirmed, 101 excluded

Canada0 confirmed, 168 excluded

Manufacturer names merged into this page: DENTAL MANUFACTURING SPA · PRIME DENTAL MANUFACTURING, INC. · PRIME DENTAL MANUFACTURING, INC · Prime Dental Manufacturing Inc. · Prime Dental Manufacturing , Inc.

FDA 510(k) clearances by year

11986

31987

21988

22000

32001

32002

12012

FDA listed device types

showing 8 of 22

Sealant, Pit And Fissure, And Conditioner 1Additively Manufactured, Preformed, Resin Denture Tooth 1Resin, Denture, Relining, Repairing, Rebasing 1Cement, Dental 1Adhesive, Bracket And Tooth Conditioner, Resin 1External Cleaning Solution 1Material, Tooth Shade, Resin 1Crown And Bridge, Temporary, Resin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K112574	PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT	2012-01-23
US	K022675	PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL	2002-11-07
US	K021524	LIGHT CURE DENTAL DAM	2002-07-19
BR	10351890013	PARAFIL® LAB	Class II
BR	80398280047	RESINA ORTODÔNTICA ONE STEP EURODONTO	Class II
SA	ME0000005597SFDAA00001	Prime Gel	—

Prime Dental Manufacturing , 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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