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Home›USA›Den-Mat Holdings,LCC

Den-Mat Holdings,LCC

USA
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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
pendingnot queried
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
Same-named companies — This database also contains companies with near-identical names: DEN-MAT HOLDINGS, LLC. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

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)

MarketIdentifierNameClass / date
USK242097DenMat Bulk Fill Composite2024-10-15
USK162967nuance UNIVERSAL2017-03-24
USK143679Nuance FLOW2015-05-01
BR80117580544PERIOPTIX LOUPE OPTICS AND FRAME SYSTEMClass I
BR10349760035CELCON M25Class II
SAME0000003108SFDAA00067PeriOptix—
CA32982MATRIXX RESTORATIVESClass III
CA74239TRUEVITALITY SYSTEMClass III
CA75128DEN-MAT HUGGER RESIN CEMENT BY TRUE VITALITYClass III

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