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FDA 510(k)

PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)

K-Number: K051464 · 2005-06-24

ApplicantPlanmeca Oy
Decision Date2005-06-24
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) is the device name listed in this FDA 510(k) record. The listed applicant is Planmeca Oy. It received FDA 510(k) clearance on 2005-06-24 under 510(k) number K051464. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)?

PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) is a medical device that received FDA 510(k) clearance on 2005-06-24. The listed applicant is Planmeca Oy. The 510(k) number is K051464.

When did PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) receive FDA 510(k) clearance?

PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) received FDA 510(k) clearance on 2005-06-24, under 510(k) number K051464.

Who is the listed applicant for PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)?

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 WITH DEC (DYNAMIC EXPOSURE CONTROL)?

The FDA product code for PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) is EHD.

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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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