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PULPDENT CORPORATION

USA · Watertown

✓ Record-verifiedregistrations found in 8 markets

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

37listed device types

Class I 26Class II 11Class III 0

plus 79 registration records and 110 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

12registered devices

Class I 1Class II 11

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

8active device licences

Class II 4Class III 4

43 including historic records

TWTaiwanTFDA

8valid device licences

Class I 1Class II 7

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

24active ARTG entries

Class I 13IIa 11

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 States79 registration records, 110 510(k), 0 PMA, 1 excluded

Brazil12 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada8 confirmed, 0 excluded

Manufacturer names merged into this page: PULPDENT CORPORATION · Pulpdent Corporation

FDA 510(k) clearances by year

61996

41997

21998

11999

32000

12001

112002

42003

12004

12006

12007

12008

22009

22010

12011

72012

12013

12016

22018

12021

FDA listed device types

showing 8 of 37

Sealant, Pit And Fissure, And Conditioner 1Device, Caries Detection 1Cement, Dental 1Adhesive, Bracket And Tooth Conditioner, Resin 1Liner, Cavity, Calcium Hydroxide 1Varnish, Cavity 1Material, Tooth Shade, Resin 1Crown And Bridge, Temporary, Resin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K210045	ACTIVA PRESTO PACK	2021-09-22
US	K173020	OBA-MCP, Orthodontic Bracket Adhesive with MCP	2018-01-17
US	K172169	Pulpdent (Activa) Pit and Fissure Sealant with MCP	2018-01-05
BR	81504799322	Ortho-Choice OBA	Class II
BR	81504799323	EMBRACE WETBOND SELANTE DE FOSSETAS E FISSURAS	Class II
BR	81504799324	EMBRACE WETBOND CIMENTO RESINOSO	Class II
SA	ME0000012595SFDAA00051	Pulpdent	—
CA	61062	ORTHO-CHOICE QUICK-BOND VLC ORTHODONTIC ADHESIVE	Class II
CA	61110	ORTHO-CHOICE NO-MIX SELF-CURE ORTHODONTIC BRACKET ADHESIVE	Class II
CA	61111	ORTHO-CHOICE TRIPLE CURE	Class II

PULPDENT 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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