Cleared Traditional

K212570 - OsteoPlan System

K212570 is an FDA 510(k) clearance for OsteoPlan System, manufactured by Osteomed, LLC. The device is a Class 2 Dental device with product code DZJ cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K212570 · Osteomed, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
179d
Days
Class 2
Risk

K212570 is an FDA 510(k) clearance for the OsteoPlan System. Classified as Driver, Wire, And Bone Drill, Manual (product code DZJ), Class II - Special Controls.

Submitted by Osteomed, LLC (Addison, US). The FDA issued a Cleared decision on February 11, 2022 after a review of 179 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - 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 Osteomed, LLC devices

FDA 510(k) Submission Details - K212570

510(k) Number K212570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2021
Decision Date February 11, 2022
Days to Decision 179 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
52d slower than avg
Panel avg: 127d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZJ Device Classification - Class 2, Special Controls

Product Code DZJ Driver, Wire, And Bone Drill, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
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 - DZJ Driver, Wire, And Bone Drill, Manual

All 23
Devices cleared under the same product code (DZJ) and FDA review panel - the closest regulatory comparables to K212570.
MedCAD AccuPlan System
K223024 · Medcad · Mar 2023
EmbedMed
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OMF ASP System
K220648 · Vha Dean · Aug 2022
CenterMed Patient Matched Assisted Surgical Planning (ASP) System
K201353 · Centermed, Inc. · Jun 2021
coDiagnostiX
K193301 · Dental Wings GmbH · Jun 2021
VSP System
K210347 · 3D Systems · Apr 2021