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FDA 510(k)

PLANMED NUANCE EXCEL

K-Number: K111361 · 2011-09-23

ApplicantPlanmeca USA, Inc.
Decision Date2011-09-23
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PLANMED NUANCE EXCEL is the device name listed in this FDA 510(k) record. The listed applicant is Planmeca USA, Inc.. It received FDA 510(k) clearance on 2011-09-23 under 510(k) number K111361. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLANMED NUANCE EXCEL?

PLANMED NUANCE EXCEL is a medical device that received FDA 510(k) clearance on 2011-09-23. The listed applicant is Planmeca USA, Inc.. The 510(k) number is K111361.

When did PLANMED NUANCE EXCEL receive FDA 510(k) clearance?

PLANMED NUANCE EXCEL received FDA 510(k) clearance on 2011-09-23, under 510(k) number K111361.

Who is the listed applicant for PLANMED NUANCE EXCEL?

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

What is the FDA product code for PLANMED NUANCE EXCEL?

The FDA product code for PLANMED NUANCE EXCEL is MUE.

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Other records listing Planmeca USA, Inc. 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.

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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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