HomeUSAROCKY MOUNTAIN ORTHODONTICS, INC - RMO

ROCKY MOUNTAIN ORTHODONTICS, INC - RMO

USA
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in Brazil, Canada, Israel — 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
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
18registered devices
Class I 5Class II 13
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
5active device licences
Class II 5
20 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
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, 0 510(k), 0 PMA, 2 excluded
Brazil18 confirmed, 1 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada5 confirmed, 0 excluded
Manufacturer names merged into this page: ORTHO AMERICA HOLDINGS LLC DBA: RMO DBA: TANGENT ORTHODONTICS · ROCKY MOUNTAIN ORTHODONTICS - RMO · ROCKY MOUNTAIN ORTHODONTICS, INC - RMO

Company information

Country
USA

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.

Registration details (sample)

MarketIdentifierNameClass / date
BR80210490017Resina Autopolimerizável TrulockTMClass II
BR80210490015TrulockClass II
BR80210499007Fio para ortodontiaClass II
CA2301ORTHODONTIC TUBE - PLASTICClass II
CA2303ORTHODONTIC WIRE - BRASSClass II
CA2307ORTHODONTIC ETCHING GELClass II

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