FDA applicant

Implant Solutions Pty Ltd (Aka Osteon Medical)

Mulgrave, AU2 decisions2022–20240 recalls

FDA records 2 decisions for Implant Solutions Pty Ltd (Aka Osteon Medical) (Mulgrave, AU) from 2022 to 2024: 2 510(k) clearances. All are in product code NHA (Abutment, Implant, Dental, Endosseous). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Implant Solutions Pty Ltd (Aka Osteon Medical)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Implant Solutions Pty Ltd (Aka Osteon Medical) by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Implant Solutions Pty Ltd (Aka Osteon…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Implant”

FDA records each applicant name separately; these may or may not be the same firm.

Implant Innovations, Inc. 51 Implant Center of the Palm Beaches 32 Implant Innovations International, Inc. 18 Implant Direct Sybron Manufacturing, LLC 17 Implant Technology, Inc. 13 Implant Support Systems, Inc. 10 Implant Direct, LLC 10 Implant Protesis Dental 2004, S.L. 6 Implant Sciences Corp. 6 Implant Integration Systems, Inc. 4 Implant Logistics, Inc. 3 Implant Corp. of America 3

Implant Solutions Pty Ltd (Aka Osteon Medical)

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Implant”