Data / Medical devices / Australia / Implant Solutions Pty Ltd (trading AS Osteon Medical)

Implant Solutions Pty Ltd (trading AS Osteon Medical): FDA-registered device maker in Mulgrave Victoria, Australia, 8 510(k) clearances

Name: Implant Solutions Pty Ltd (trading AS Osteon Medical) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Implant Solutions Pty Ltd (trading AS Osteon Medical) is registered with the FDA (registration 3018501314) in Mulgrave Victoria, Australia. It lists 8 device types. The FDA files 8 510(k) clearances under its listings, the newest dated April 24, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3018501314
Address: 759 - 767 Springvale Road, Mulgrave Victoria, Australia, 3170
Owner or operator: Osteon Medical (10081414)
Roles: Exporter to the US, Manufacturer
First device listed: April 12, 2021
Registered through: 2026
Brand names listed: DESS Dental Smart Solutions, Osteon Precision Milled Suprastructure, Osteon Prosthesis, Osteon Scan Gauge Kit

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Dentures, Full	NSL	N	Manufacturer	accessdata.fda.gov
Dentures, Partial	NSK	N	Manufacturer	accessdata.fda.gov
Restoration, Base Metal	NSQ	N	Manufacturer	accessdata.fda.gov
Restoration, Porcelain	NSP	N	Manufacturer	accessdata.fda.gov
Restoration, Resin	NSM	N	Manufacturer	accessdata.fda.gov
Restoration, Resin, Crown And Bridge	NSN	N	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 24, 2024	K240208	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov
March 9, 2024	K233083	Osteon Precision Milled Suprastructure	NHA	Substantially Equivalent	Implant Solutions Pty Ltd (Aka Osteon Medical)	accessdata.fda.gov
July 5, 2022	K221019	Osteon Precision Milled Suprastructure	NHA	Substantially Equivalent	Implant Solutions Pty Ltd (Aka Osteon Medical)	accessdata.fda.gov
March 3, 2022	K212676	Osteon Precision Milled Suprastructure	NHA	Substantially Equivalent	Implant Solutions Pty Ltd (Osteon Medical)	accessdata.fda.gov
August 4, 2021	K203464	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov
November 10, 2019	K191986	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov
June 15, 2018	K173908	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov
August 8, 2017	K170588	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov

Compare with other makers

Updated April 24, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.