Cleared Traditional

K160506 - Planmeca ProMax 3D Max

K160506 is the FDA 510(k) clearance for Planmeca ProMax 3D Max by Planmeca Oy. It is a Class 2 Radiology device (product code OAS) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K160506 · Planmeca Oy · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
86d
Days
Class 2
Risk

K160506 is an FDA 510(k) clearance for the Planmeca ProMax 3D Max, Planmeca Maximity. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on May 20, 2016 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Planmeca Oy devices

Submission Details

510(k) Number K160506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2016
Decision Date May 20, 2016
Days to Decision 86 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAS X-ray, Tomography, Computed, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.
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 Radiology devices follow this clearance model.

Regulatory Peers - OAS X-ray, Tomography, Computed, Dental

All 90
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