Home›USA›DEN-MAT HOLDINGS, LLC

DEN-MAT HOLDINGS, LLC

USA · Lompoc

✓ Record-verifiedregistrations found in 5 markets

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

42listed device types

Class I 27Class II 14Class III 0unclassified 1

plus 84 registration records and 37 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

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

13active device licences

Class II 4Class III 9

50 including historic records

TWTaiwanTFDA

4valid device licences

Class I 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States84 registration records, 37 510(k), 0 PMA, 5 excluded

Brazil2 confirmed, 1 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada13 confirmed, 0 excluded

Manufacturer names merged into this page: DEN-MAT HOLDINGS, LLC · DEN-MAT HOLDINGS, LLC (DBA CLINICIAN'S CHOICE) [CLINICIAN'S CHOICE, · CLINICIAN'S CHOICE, A DIVISION OF DEN-MAT HOLDINGS, LLC · Den-Mat Holdings,LCC · Den-Mat Holdings

FDA 510(k) clearances by year

21977

51978

51979

31980

11983

11984

21985

21986

31987

21988

21990

11999

22008

12010

12011

12014

12015

12017

12024

FDA listed device types

showing 8 of 42

Toothbrush, Powered 1Syringe, Restorative And Impression Material 1Point, Abrasive 1Pick, Massaging 1Syringe, Irrigating (Dental) 1Instruments, Dental Hand 1Disk, Abrasive 1Tip, Rubber, Oral Hygiene 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242097	DenMat Bulk Fill Composite	2024-10-15
US	K162967	nuance UNIVERSAL	2017-03-24
US	K143679	Nuance FLOW	2015-05-01
BR	80117580544	PERIOPTIX LOUPE OPTICS AND FRAME SYSTEM	Class I
BR	10349760035	CELCON M25	Class II
SA	ME0000003108SFDAA00067	PeriOptix	—
CA	32982	MATRIXX RESTORATIVES	Class III
CA	74239	TRUEVITALITY SYSTEM	Class III
CA	75128	DEN-MAT HUGGER RESIN CEMENT BY TRUE VITALITY	Class III

DEN-MAT HOLDINGS, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies