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ADDENT, INC.

USA · Danbury

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 2 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

10listed device types

Class I 7Class II 3Class III 0

plus 8 registration records and 7 510(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

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 4

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 States8 registration records, 7 510(k), 0 PMA

Manufacturer names merged into this page: ADDENT, INC.

FDA 510(k) clearances by year

12005 · K041614

12006 · K061395

22007 · K072309

12009 · K082668

12012 · K121282

12019 · K182017

FDA listed device types

showing 8 of 10

Light Transmission Caries Detector 1Activator, Ultraviolet, For Polymerization 1Diagnostic Light, Soft Tissue Detector 1Instruments, Dental Hand 1Warmer, Anesthetic Tube 1Applicator, Resin 1Light, Operating, Dental 1Composite Resin Warmer 1

Market	Identifier	Name	Class / date
US	K182017	Compex HD	2019-04-29
US	K121282	MICROLUX/DL MICROLUX/BLU BIO/SCREEN	2012-07-24
US	K082668	BIO-SCREEN	2009-01-23

ADDENT, INC.

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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