Home›USA›AMERICAN ORTHODONTICS CORPORATION

AMERICAN ORTHODONTICS CORPORATION

USA · Sheboygan

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 10 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

35listed device types

Class I 26Class II 9Class III 0

plus 50 registration records and 46 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

27registered devices

Class I 5Class II 22

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

38registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

28 including historic records

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

57active ARTG entries

Class I 33IIa 24

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 3

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 States50 registration records, 46 510(k), 0 PMA, 41 excluded

Brazil27 confirmed, 13 excluded

Saudi Arabia38 confirmed, 4 excluded

Canada0 confirmed, 14 excluded

Manufacturer names merged into this page: AMERICAN ORTHODONTICS · AMERICAN ORTHODONTICS CORP · AMERICAN ORTHODONTICS CORPORATION · American Orthodontics · American Orthodontics Corporation

FDA 510(k) clearances by year

271989

41990

11991

11992

31993

12008

12012

12015

12016

22018

12020

12023

12024

12026

FDA listed device types

showing 8 of 35

Activator, Ultraviolet, For Polymerization 1Cement, Dental 1Adhesive, Bracket And Tooth Conditioner, Resin 1Bracket, Ceramic, Orthodontic 1Headgear, Extraoral, Orthodontic 1Material, Tooth Shade, Resin 1Material, Impression 1Agent, Tooth Bonding, Resin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261840	BracePaste Prime Plus	2026-06-03
US	K242537	BracePaste Fluoride Sealant	2024-08-27
US	K232011	Cleo	2023-07-07
BR	80755769001	BracePaste Adhesive	Class II
BR	80755760011	EMPOWER 2 CLEAR	Class II
BR	80755760019	BRACEPASTE MTP PRIMER	Class II
SA	ME0000014422SFDAA00002	Wire	—
SA	ME0000014422SFDAA00003	Direct Bond Tubes	—

AMERICAN ORTHODONTICS CORPORATION

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies