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FDA 510(k)

PLANMECA PROMAX 3D

K-Number: K060328 · 2006-03-15

ApplicantPlanmeca Oy
Decision Date2006-03-15
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PLANMECA PROMAX 3D is the device name listed in this FDA 510(k) record. The listed applicant is Planmeca Oy. It received FDA 510(k) clearance on 2006-03-15 under 510(k) number K060328. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLANMECA PROMAX 3D?

PLANMECA PROMAX 3D is a medical device that received FDA 510(k) clearance on 2006-03-15. The listed applicant is Planmeca Oy. The 510(k) number is K060328.

When did PLANMECA PROMAX 3D receive FDA 510(k) clearance?

PLANMECA PROMAX 3D received FDA 510(k) clearance on 2006-03-15, under 510(k) number K060328.

Who is the listed applicant for PLANMECA PROMAX 3D?

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 PROMAX 3D?

The FDA product code for PLANMECA PROMAX 3D is MUH.

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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.

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Related Devices (Code: MUH)

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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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