Planmeca ProMax 3D Max, Planmeca Maximity
K-Number: K160506 · 2016-05-20
ApplicantPlanmeca Oy
Decision Date2016-05-20
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Planmeca ProMax 3D Max, Planmeca Maximity is a medical device manufactured by Planmeca Oy. It received FDA 510(k) clearance on 2016-05-20 under approval number K160506. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Planmeca ProMax 3D Max, Planmeca Maximity?
Planmeca ProMax 3D Max, Planmeca Maximity is a medical device that received FDA 510(k) clearance on 2016-05-20. It is manufactured by Planmeca Oy. The 510(k) number is K160506.
When was Planmeca ProMax 3D Max, Planmeca Maximity approved by the FDA?
Planmeca ProMax 3D Max, Planmeca Maximity received FDA 510(k) clearance on 2016-05-20, under approval number K160506.
What company makes Planmeca ProMax 3D Max, Planmeca Maximity?
Planmeca ProMax 3D Max, Planmeca Maximity is manufactured by Planmeca Oy.
What is the FDA product code for Planmeca ProMax 3D Max, Planmeca Maximity?
The FDA product code for Planmeca ProMax 3D Max, Planmeca Maximity is OAS.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.