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Lancer Orthodontics, Inc.

USA · Carlsbad

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Australia — 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

14510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

7active device licences

Class II 7

13 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 3IIa 1

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 States0 registration records, 14 510(k), 0 PMA, 3 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: LANCER ORTHODONTICS INC. · LANCER ORTHODONTICS, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K122069	STORM MINI SCREW	2013-04-11
US	K071192	BLUGOO HD	2007-06-22
US	K051552	O.A.S.I. SYSTEM	2005-09-19
SA	ME0000004813SFDAA00003	Tube	—
CA	74601	INTRIGUE BRACKETS	Class II
CA	82475	SPACERS	Class II
CA	82476	ORTHODONTIC NICKEL-FREE BRACKETS	Class II

Lancer Orthodontics, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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