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Implant Solutions Pty Ltd (Aka Osteon Medical)

Australia · Mulgrave

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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

8listed device types

Class I 1Class II 1Class III 0unclassified 6

plus 24 registration records and 3 510(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

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States24 registration records, 3 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: IMPLANT SOLUTIONS PTY LTD (TRADING AS OSTEON MEDICAL)

Same-named companies — This database also contains companies with near-identical names: Implant Solutions Pty Ltd (Osteon Medical), IMPLANT SOLUTIONS PTY LTD (TRADING AS OSTEON MEDICAL). Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

22022 · K221019

12024 · K233083

FDA listed device types

Accessories, Implant, Dental, Endosseous 1Restoration, Resin, Crown And Bridge 1Restoration, Resin 1Dentures, Partial 1Restoration, Base Metal 1Dentures, Full 1Restoration, Porcelain 1Abutment, Implant, Dental, Endosseous 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233083	Osteon Precision Milled Suprastructure	2024-03-09
US	K221019	Osteon Precision Milled Suprastructure	2022-07-05
US	K212676	Osteon Precision Milled Suprastructure	2022-03-03

Implant Solutions Pty Ltd (Aka Osteon Medical)

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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