HomeFranceBiotech Dental Smilers, SAS

Biotech Dental Smilers, SAS

France · Salon De Provence
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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
4listed device types
Class I 3Class II 1Class III 0
plus 4 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
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 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 States4 registration records, 1 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: Biotech Dental Smilers, SAS · BIOTECH DENTAL SMILERS · BIOTECH DENTAL SMILERS S.A.S

Company information

Country
France
City
Salon De Provence

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

12021 · K212961

FDA listed device types

Toothbrush, Powered 1Positioner, Tooth, Preformed 1Aligner, Bracket, Orthodontic 1Aligner, Sequential 1

Registration details (sample)

MarketIdentifierNameClass / date
USK212961SMILERS2021-09-20
BR81372440033FROGGYMOUTH®Class I

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