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ORTHO-TAIN, INC.

USA · Toa Alta

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Australia, Russia — 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

3listed device types

Class I 3Class II 0Class III 0

plus 3 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 2Class II 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

2 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 States3 registration records, 2 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: ORTHO-TAIN, INC. · ORTHO-TAIN INC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K980952	SNORE-CURE ANTI-SNORING APPLIANCE	1998-06-01
US	K931615	NITE-GUIDE	1995-04-14
BR	80027090001	APARELHO PARA CORRECAO ORTODONTICA ORTHO-TAIN	Class II
BR	80027090020	HABIT CORRECTOR	Class I
BR	80027090014	Snore-Cure	Class I

ORTHO-TAIN, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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