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FDA 510(k)

PLANMECA PROMAX 3D MID

K-Number: K103689 · 2011-03-17

ApplicantPlanmeca Oy
Decision Date2011-03-17
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PLANMECA PROMAX 3D MID is the device name listed in this FDA 510(k) record. The listed applicant is Planmeca Oy. It received FDA 510(k) clearance on 2011-03-17 under 510(k) number K103689. 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 MID?

PLANMECA PROMAX 3D MID is a medical device that received FDA 510(k) clearance on 2011-03-17. The listed applicant is Planmeca Oy. The 510(k) number is K103689.

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

PLANMECA PROMAX 3D MID received FDA 510(k) clearance on 2011-03-17, under 510(k) number K103689.

Who is the listed applicant for PLANMECA PROMAX 3D MID?

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 MID?

The FDA product code for PLANMECA PROMAX 3D MID 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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