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Impladent , Ltd.

USA · Northborough

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Israel — 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

5listed device types

Class I 0Class II 4Class III 0unclassified 1

plus 4 registration records and 10 510(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

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 States4 registration records, 10 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: IMPLADENT, LTD.

FDA 510(k) clearances by year

11980

11981

11984

11988

11995

11996

11999

12004

12009

12014

FDA listed device types

Wound Dressing With Animal-Derived Material(S) 1Bone Grafting Material, Animal Source 1Bone Grafting Material, Synthetic 1Screw, Fixation, Intraosseous 1Plate, Bone 1

Market	Identifier	Name	Class / date
US	K141764	TRISTAR BONE GRAFT FIXATION SYSTEM	2014-12-18
US	K090794	OSTEOTAPE	2009-12-10
US	K033098	OSTEOGEN SBRG	2004-04-27

Impladent , Ltd.

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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