HomeUSAS. S. WHITE BURS, INC.

S. S. WHITE BURS, INC.

USA · Lakewood
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel, Russia — 9 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
9listed device types
Class I 8Class II 1Class III 0
plus 9 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
8registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
9 including historic records
TWTaiwanTFDA
4valid device licences
Class I 4
SGSingaporeHSA SMDR
3device registrations
CLASS B 3
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
7active ARTG entries
IIa 7
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
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 States9 registration records, 1 510(k), 0 PMA
Brazil1 confirmed, 1 excluded
Saudi Arabia8 confirmed, 0 excluded
Manufacturer names merged into this page: SS WHITE BURS LLC · S. S. WHITE BURS, INC. · S.S. White Burs Inc.
Same-named companies — This database also contains companies with near-identical names: SS WHITE INC., SS WHITE BURS LLC. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Lakewood

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

12008 · K080687

FDA listed device types

showing 8 of 9
Point, Paper, Endodontic 1Bur, Dental 1Syringe, Periodontic, Endodontic, Irrigating 1Point, Abrasive 1Gutta-Percha 1File, Pulp Canal, Endodontic 1Strip, Polishing Agent 1Instrument, Diamond, Dental 1

Registration details (sample)

MarketIdentifierNameClass / date
USK080687SMARTBURS2008-06-20
BR80149710210BROCA CARBIDEClass I
SAME0000008270SFDAA00001Diamond
SAME0000008271SFDAA00002Great White

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