Osteon Precision Milled Suprastructure— 510(k) K212676

Name: FDA 510(k) clearance K212676
Creator: U.S. Food and Drug Administration
Published: 2022-03-03

Substantially Equivalent

Implant Solutions Pty Ltd (Osteon Medical)

FDA 510(k) clearance K212676 for Osteon Precision Milled Suprastructure, Substantially Equivalent on 2022-03-03. Applicant: Implant Solutions Pty Ltd (Osteon Medical). Device class: 2.

Clearance details

Applicant: Implant Solutions Pty Ltd (Osteon Medical)
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2021-08-24
Decision date: 2022-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mulgrave, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code NHA

view all

K253999 — Universal Base ASC Engaging +6 more2026-08-06
K261147 — Neodent Implant System - NeoConvert Fit2026-07-01
K261122 — MIST IC2026-06-27
K260061 — BioHorizons CEREC Compatible Ti-Bases2026-06-26
K253922 — Neodent Scannable Healing Abutment2026-06-15

Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.