Home›USA›Ortho Solutions LC

Ortho Solutions LC

USA · Lake Saint Louis

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

49listed device types

Class I 38Class II 11Class III 0

plus 59 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class 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

0active device licences

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 States59 registration records, 0 510(k), 0 PMA, 12 excluded

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: Ortho Solutions LC · ORTHO SOLUTIONS LC DBA DYNAFLEX

FDA listed device types

showing 8 of 49

Pusher, Band, Orthodontic 1Forceps 1Aligner, Bracket, Orthodontic 1Positioner, Tooth, Preformed 1Band, Preformed, Orthodontic 1Toothbrush, Manual 1Material, Impression Tray, Resin 1Setter, Band, Orthodontic 1

Market	Identifier	Name	Class / date
BR	80027099002	PLACA GLACIER LTR	Class II
BR	80027099003	PLACA GLACIER ULTRA PREMIUM	Class II

Ortho Solutions LC

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

Similar companies