Home›USA›A-dec, Inc.

A-dec, Inc.

USA · Newberg

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Taiwan, Australia, Hong Kong, Israel, Russia — 7 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

24listed device types

Class I 17Class II 6Class III 0unclassified 1

plus 51 registration records and 69 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

17active device licences

Class II 17

27 including historic records

TWTaiwanTFDA

4valid device licences

Class I 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

9active ARTG entries

Class I 2IIa 6IIb 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

6active registrations

Class 1 1Class 2a 5

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 States51 registration records, 69 510(k), 0 PMA, 1 excluded

Canada17 confirmed, 0 excluded

Manufacturer names merged into this page: A-dec, Inc. · A-DEC, INC.

FDA 510(k) clearances by year

21989

61990

21991

181993

61994

131995

21996

11999

42000

12001

52003

12005

12007

12008

22009

22010

12014

12022

FDA listed device types

showing 8 of 24

Unit, Syringe, Air And/Or Water 1Controller, Foot, Handpiece And Cord 1Handpiece, Air-Powered, Dental 1Accessory, Surgical Apparel 1Unit, Operative Dental 1Handpiece, Direct Drive, Ac-Powered 1Unit, Operative Dental, Accessories 1Light, Operating, Dental 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213932	A-dec 300, A-dec 500	2022-03-02
US	K133776	A-DEC/W&H ELECTRIC HANDPIECE MOTOR	2014-05-28
US	K102234	A-DEC 200 DENTAL SYSTEM	2010-11-24
CA	2067	ASSISTANT'S INSTRUMENTATION	Class II
CA	2078	AUTOCLAVABLE SYRINGE	Class II
CA	2116	CORSAIR II 7555 SCALER	Class II

A-dec, Inc.

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