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Discus Dental, Inc.

USA · Los Angeles

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Saudi Arabia, Canada, Singapore, Australia, Israel, Russia — 7 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

13listed device types

Class I 12Class II 1Class III 0

plus 13 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

9active device licences

Class II 6Class III 3

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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 States13 registration records, 15 510(k), 0 PMA

Saudi Arabia3 confirmed, 0 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: DISCUS DENTAL, LLC · Discus Dental LLC

FDA 510(k) clearances by year

12002

22003

32004

22005

22007

12009

42010

FDA listed device types

showing 8 of 13

Absorber, Saliva, Paper 1Toothbrush, Powered 1Oral Irrigation Kit 1Accessories, Retractor, Dental 1Cotton, Roll 1Dam, Rubber 1Shield, Eye, Radiological 1Unit, Oral Irrigation 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K102639	SL3	2010-12-01
US	K101612	ZEN CORDLESS PROPHY SYSTEM	2010-06-30
US	K101215	NUANCE	2010-05-12
SA	ME0000002178SFDAA00002	Philips Zoom WhiteSpeed Whitening LED Accelerator	—
SA	ME0000002178SFDAA00001	Relief ACP	—
CA	15232	PERFECTEMP TEMPORARY CEMENT MATERIAL	Class II
CA	17680	MATRIXX CABRIO ADHESIVE SYSTEM	Class III
CA	68951	PROTEGE ULTRASONIC INSERT (SCALING DEVICE)	Class II

Discus Dental, 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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