HomeUSADanville Materials, Inc.

Danville Materials, Inc.

USA · Carlsbad
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore — 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
10listed device types
Class I 2Class II 8Class III 0
plus 20 registration records and 16 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class III 1
25 including historic records
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
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 States20 registration records, 16 510(k), 0 PMA, 1 excluded
Brazil1 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: Danville Materials Research Center · DANVILLE MATERIALS · DANVILLE MATERIALS INC
Same-named companies — This database also contains companies with near-identical names: Danville Materials Research Center. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Carlsbad

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

12001
12002
22004
32009
32011
12012
52015

FDA listed device types

showing 8 of 10
Sealant, Pit And Fissure, And Conditioner 1Resin, Denture, Relining, Repairing, Rebasing 1Material, Tooth Shade, Resin 1Material, Impression 1Airbrush 1Crown And Bridge, Temporary, Resin 1Crown And Bridge, Long-Term Temporary, Resin 1Agent, Tooth Bonding, Resin 1

Registration details (sample)

MarketIdentifierNameClass / date
USK152349Star+ VPS Scannable Impression Material2015-11-23
USK151514Prestige2015-09-21
USK151088DMRC Bulk Fill2015-08-28
BR80424450009CONTACT MATRIXClass II
CA93796ZNANO UNIVERSAL NANOCOMPOSITE/ZNANOFLOW UNIVERSAL FLOWABLE NANOCOMPOSITEClass III

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