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Centrix Incorporated

USA · Shelton

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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

19listed device types

Class I 8Class II 10Class III 0unclassified 1

plus 38 registration records and 48 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

12active device licences

Class II 3Class III 9

35 including historic records

TWTaiwanTFDA

4valid device licences

Class I 2Class II 2

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

19active ARTG entries

Class I 12IIa 7

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 3

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 States38 registration records, 48 510(k), 0 PMA

Saudi Arabia2 confirmed, 0 excluded

Canada12 confirmed, 0 excluded

Manufacturer names merged into this page: CENTRIX, INC. · CENTRIX INCORPORATED · Centrix, Inc

FDA 510(k) clearances by year

31989

41992

21993

31994

21995

31996

41997

41998

11999

12000

12001

22002

22009

12011

12012

12014

12016

12020

12023

12025

FDA listed device types

showing 8 of 19

Sealant, Pit And Fissure, And Conditioner 1Device, Caries Detection 1Cement, Dental 1Liner, Cavity, Calcium Hydroxide 1Diammine Silver Fluoride Dental Hypersensitivity Varnish 1Material, Tooth Shade, Resin 1Material, Impression 1Varnish, Cavity 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250714	FluoroDose Varnish	2025-11-21
US	K222459	Centrix FluoroSilver Silver Diamine Fluoride 38%	2023-10-27
US	K200764	STATSTIX	2020-10-15
SA	ME0000006799SFDAA00004	GripStrip	—
SA	ME0000006799SFDAA00005	ProxiDiscs	—
CA	70492	PROXIDISCS INTERPROXIMAL CONTACT DISCS	Class II
CA	70496	ACCESS AUTOMIX TIPS	Class II
CA	70497	MIN-IDENTOFLEX POLISHERS	Class II

Centrix Incorporated

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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