Planmeca Romexis
K-Number: K200572 · 2020-12-02
ApplicantPlanmeca Oy
Decision Date2020-12-02
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 2020-12-02 under approval number K200572. 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 2020-12-02. It is manufactured by Planmeca Oy. The 510(k) number is K200572.
When was Planmeca Romexis approved by the FDA?
Planmeca Romexis received FDA 510(k) clearance on 2020-12-02, under approval number K200572.
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
Related Devices (Code: LLZ)
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.