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FDA 510(k)

Planmeca Viso

K-Number: K230985 · 2023-12-28

ApplicantPlanmeca Oy
Decision Date2023-12-28
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Planmeca Viso is a medical device manufactured by Planmeca Oy. It received FDA 510(k) clearance on 2023-12-28 under approval number K230985. 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 Viso?

Planmeca Viso is a medical device that received FDA 510(k) clearance on 2023-12-28. It is manufactured by Planmeca Oy. The 510(k) number is K230985.

When was Planmeca Viso approved by the FDA?

Planmeca Viso received FDA 510(k) clearance on 2023-12-28, under approval number K230985.

What company makes Planmeca Viso?

Planmeca Viso is manufactured by Planmeca Oy.

What is the FDA product code for Planmeca Viso?

The FDA product code for Planmeca Viso is OAS.

Other Devices by Planmeca Oy

K160506Planmeca ProMax 3D Max, Planmeca Maximity K171385Planmeca Romexis K181576Planmeca Viso K200572Planmeca Romexis

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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.

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