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Ormco Corporation

USA · San Diego

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

37listed device types

Class I 27Class II 10Class III 0

plus 109 registration records and 46 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

37registered devices

Class I 5Class II 32

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

SASaudi ArabiaSFDA

6registered imported devices

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

CACanadaMDALL

9active device licences

Class II 9

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 States109 registration records, 46 510(k), 0 PMA, 1 excluded

Brazil37 confirmed, 1 excluded

Saudi Arabia6 confirmed, 3 excluded

Canada9 confirmed, 3 excluded

Manufacturer names merged into this page: Ormco Corporation · ORMCO CORPORATION

FDA 510(k) clearances by year

51990

11991

51992

21993

21994

31995

11996

12005

22006

22008

12010

12011

12012

32013

12014

12017

12018

12021

12024

22025

FDA listed device types

showing 8 of 37

Cement, Dental 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Adhesive, Bracket And Tooth Conditioner, Resin 1Bracket, Ceramic, Orthodontic 1Implant, Endosseous, Orthodontic 1Headgear, Extraoral, Orthodontic 1Orthodontic Software 1Agent, Tooth Bonding, Resin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250487	SparkTM Clear Aligner System	2025-02-20
US	K250015	Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive	2025-01-03
US	K240501	Spark Clear Aligner System	2024-10-11
BR	10064010256	KIT DAMON SPK 740-1401	Class II
BR	10064010260	KIT DAMON SPK 740-1400	Class II
BR	10064010257	KIT DAMON SPK 740-1402	Class II
SA	ME0000007036SFDAA00001	BRITE-GEAR	—
SA	ME0000018081SFDAA00003	Orthos	—
CA	2899	BAND CEMENT	Class II
CA	2900	ORTHODONTIC BONDING ADHESIVE	Class II
CA	2901	ORTHODONTIC ELASTICS	Class II

Ormco Corporation

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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