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FDA 510(k)

DIXI 2

K-Number: K000428 · 2000-04-28

ApplicantPlanmeca Oy
Decision Date2000-04-28
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIXI 2 is the device name listed in this FDA 510(k) record. The listed applicant is Planmeca Oy. It received FDA 510(k) clearance on 2000-04-28 under 510(k) number K000428. 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 DIXI 2?

DIXI 2 is a medical device that received FDA 510(k) clearance on 2000-04-28. The listed applicant is Planmeca Oy. The 510(k) number is K000428.

When did DIXI 2 receive FDA 510(k) clearance?

DIXI 2 received FDA 510(k) clearance on 2000-04-28, under 510(k) number K000428.

Who is the listed applicant for DIXI 2?

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 DIXI 2?

The FDA product code for DIXI 2 is EHD.

Other records listing Planmeca Oy as applicant

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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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