Cleared Traditional

Osteon Precision Milled Suprastructure (K233083) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233083 · Implant Solutions Pty Ltd (Aka Osteon Medical) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
165d
Days
Class 2
Risk

K233083 is an FDA 510(k) clearance for the Osteon Precision Milled Suprastructure. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Implant Solutions Pty Ltd (Aka Osteon Medical) (Mulgrave, AU). The FDA issued a Cleared decision on March 9, 2024 after a review of 165 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Implant Solutions Pty Ltd (Aka Osteon Medical) devices

Submission Details

510(k) Number K233083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2023
Decision Date March 09, 2024
Days to Decision 165 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 127d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

All 318
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K233083.
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
K223113 · Medentika GmbH · Apr 2024
J & P Click Attachments
K231132 · J & P Dental Technologies · Mar 2024
LW Implant System – Abutment
K233167 · Ossvis Co., Ltd. · Mar 2024
DGA Abutment
K231210 · Modern Dental Laboratory (Dg) Co., Ltd. · Mar 2024
Zfx Abutments
K231915 · Zfx GmbH - A Company of Zimvie · Mar 2024
Oneday Implant Abutment
K231753 · Oneday Biotech Co., Ltd. · Feb 2024