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Dental Devices

✓ Record-verifiedregistrations found in 5 markets

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

7listed device types

Class I 5Class II 2Class III 0

plus 13 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

16registered imported devices

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

CACanadaMDALL

0active device licences

7 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States13 registration records, 5 510(k), 0 PMA, 894 excluded

Brazil0 confirmed, 133 excluded

Saudi Arabia16 confirmed, 101 excluded

Canada0 confirmed, 168 excluded

Manufacturer names merged into this page: A.B. DENTAL DEVICES LTD · A.B. DENTAL DEVICES, LTD. · Dental Devices

FDA 510(k) clearances by year

11993 · K924118

12006 · K051719

12012 · K112440

12014 · K132125

12026 · K250806

FDA listed device types

Implant, Endosseous, Root-Form 1Abutment, Implant, Dental, Endosseous 1Instruments, Dental Hand 1Accessories, Implant, Dental, Endosseous 1Handle, Instrument, Dental 1Elevator, Surgical, Dental 1Drill, Dental, Intraoral 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250806	Dental Implant System	2026-06-18
US	K132125	A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM	2014-01-21
US	K112440	AB DENTAL DEVICES IMPLANTS AND ACCESSORIES	2012-04-18
SA	ME0000007914SFDAA00001	Scissors	—
SA	ME0000007914SFDAA00002	Matrix Retainer	—

Dental Devices

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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