HomeUSAPropel Orthodontics, LLC

Propel Orthodontics, LLC

USA · San Jose
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, Israel — 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
3510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class I 1Class II 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
4active device licences
Class II 4
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States0 registration records, 3 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: PROPEL ORTHODONTICS, LLC · PROPEL Orthodontics

Company information

Country
USA
City
San Jose

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

12015 · K150392
12018 · K172164
12019 · K183018

Registration details (sample)

MarketIdentifierNameClass / date
USK183018VPro52019-11-01
USK172164PROPEL Device2018-01-17
USK150392PROPEL device2015-09-18
BR81774499001VPRO5 - Dispositivo de Vibração C-ShapedClass II
BR81774499002moldeira v-pro5Class II
BR81774490002Instrumental Excellerator RTClass I
CA94646MANUAL DENTAL INSTRUMENT, DRILL TIPClass II
CA97060C-SHAPED VIBRATION DEVICE, VPRO ROWClass II
CA101999VPRO+ VIBRATION DEVICEClass II

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