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3M Company, Unitek Orthodontic Products

USA · Saint Paul

✓ Record-verifiedregistrations found in 5 markets

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

13510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

39registered devices

Class I 12Class II 27

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

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

21 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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, 13 510(k), 0 PMA, 1 excluded

Brazil39 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: 3M UNITEK CORPORATION DBA 3M UNITEK ORTHODONTIC PRODUCTS · 3M UNITEK · 3M UNITEK CORPORATION · 3M UNITEK ORTHODONTIC PRODUCTS · 3M UNITEK DENTAL PRODUCTS · 3M Unitek Corporation dba 3M Unitek Orthodontic Products

Same-named companies — This database also contains companies with near-identical names: 3M Unitek Corporation, 3M UNITEK CORPORATION DBA 3M UNITEK ORTHODONTIC PRODUCTS, 3M UNITEK DENTAL PRODUCTS. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K234043	3M Transbond Orthodontic Adhesive	2023-12-22
US	K233257	3M ClarityAligners with Quick Attachments	2023-09-29
US	K231464	3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)	2023-05-22
BR	10002070088	FIO EM NIQUEL/TITANIO PARA ORTODONTIA 3M UNITEK	Class II
BR	10002070095	FIO EM ACO PARA ORTODONTIA 3M UNITEK	Class II
BR	10002070091	BRACKET METALICO PARA ORTODONTIA 3M UNITEK	Class II
SA	ME0000009305SFDAA00034	Ortholux™ Luminous Curing Light	—
SA	ME0000009321SFDAA00001	Victory SeriesTM Low Profile, and Miniature Twin	—
CA	57	MINI UNI-TWIN MESH BASE BRACKET APC BRACKETS	Class II
CA	31324	TRACTION RELEASE	Class II

3M Company, Unitek Orthodontic Products

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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