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FDA 510(k)

Planmeca Romexis

K-Number: K171385 · 2017-11-14

ApplicantPlanmeca Oy
Decision Date2017-11-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Planmeca Romexis is a medical device manufactured by Planmeca Oy. It received FDA 510(k) clearance on 2017-11-14 under approval number K171385. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Planmeca Romexis?

Planmeca Romexis is a medical device that received FDA 510(k) clearance on 2017-11-14. It is manufactured by Planmeca Oy. The 510(k) number is K171385.

When was Planmeca Romexis approved by the FDA?

Planmeca Romexis received FDA 510(k) clearance on 2017-11-14, under approval number K171385.

What company makes Planmeca Romexis?

Planmeca Romexis is manufactured by Planmeca Oy.

What is the FDA product code for Planmeca Romexis?

The FDA product code for Planmeca Romexis is LLZ.

Other Devices by Planmeca Oy

K160506Planmeca ProMax 3D Max, Planmeca Maximity K181576Planmeca Viso K200572Planmeca Romexis K230985Planmeca Viso

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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