FDA 510(k)

Planmeca Romexis

K-Number: K171385 · 2017-11-14

Decision Date2017-11-14

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Planmeca Romexis is the device name listed in this FDA 510(k) record. The listed applicant is Planmeca Oy. It received FDA 510(k) clearance on 2017-11-14 under 510(k) 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. The listed applicant is Planmeca Oy. The 510(k) number is K171385.

When did Planmeca Romexis receive FDA 510(k) clearance?

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

Who is the listed applicant for Planmeca Romexis?

The FDA 510(k) record lists Planmeca Oy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Planmeca Romexis?

The FDA product code for Planmeca Romexis is LLZ.

Other records listing Planmeca Oy as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: LLZ)

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, Inc.

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.