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FDA 510(k)

X O ODONTOSURGE 4

K-Number: K023672 · 2003-04-29

ApplicantXo Care A/S
Decision Date2003-04-29
Product CodeEKZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

X O ODONTOSURGE 4 is the device name listed in this FDA 510(k) record. The listed applicant is Xo Care A/S. It received FDA 510(k) clearance on 2003-04-29 under 510(k) number K023672. The device is classified under product code EKZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X O ODONTOSURGE 4?

X O ODONTOSURGE 4 is a medical device that received FDA 510(k) clearance on 2003-04-29. The listed applicant is Xo Care A/S. The 510(k) number is K023672.

When did X O ODONTOSURGE 4 receive FDA 510(k) clearance?

X O ODONTOSURGE 4 received FDA 510(k) clearance on 2003-04-29, under 510(k) number K023672.

Who is the listed applicant for X O ODONTOSURGE 4?

The FDA 510(k) record lists Xo Care A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X O ODONTOSURGE 4?

The FDA product code for X O ODONTOSURGE 4 is EKZ.

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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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