Cleared Traditional

Planmeca ProMax 3D Max, Planmeca Maximity

K160506 · Planmeca Oy · Radiology
May 2016
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K160506 is an FDA 510(k) clearance for the Planmeca ProMax 3D Max, Planmeca Maximity, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on May 20, 2016, 86 days after receiving the submission on February 24, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K160506 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code OAS — X-ray, Tomography, Computed, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.