HomeUSADental Concepts, LLC

Dental Concepts, LLC

USA · North Attleboro
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Australia — 3 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
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 2
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
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
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 States1 registration records, 6 510(k), 0 PMA, 107 excluded
Brazil2 confirmed, 7 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 11 excluded
Manufacturer names merged into this page: CREATIVE DENTAL CONCEPTS LLC · CREATIVE DENTAL CONCEPTS – LLC

Company information

Country
USA
City
North Attleboro

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

11984 · K844238
12000 · K001541
12002 · K020957
12003 · K024261
12006 · K053580
12007 · K070535

FDA listed device types

Handle, Instrument, Dental 1

Registration details (sample)

MarketIdentifierNameClass / date
USK070535RETROPAN CCD-TWAIN-USB2007-04-24
USK053580DOCTOR'S NIGHTGUARD2006-03-03
USK024261DENTAL PROTECTOR2003-03-26
BR81481070010TIRA DE LIXA - QWIK STRIPSClass I
BR81481070011KIT - TIRA DE LIXA - QWIK STRIPSClass I

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