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FDA 510(k)

ODONTOSURGE 3

K-Number: K001560 · 2000-08-24

ApplicantOdonto-Wave
Decision Date2000-08-24
Product CodeEKZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ODONTOSURGE 3 is the device name listed in this FDA 510(k) record. The listed applicant is Odonto-Wave. It received FDA 510(k) clearance on 2000-08-24 under 510(k) number K001560. 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 ODONTOSURGE 3?

ODONTOSURGE 3 is a medical device that received FDA 510(k) clearance on 2000-08-24. The listed applicant is Odonto-Wave. The 510(k) number is K001560.

When did ODONTOSURGE 3 receive FDA 510(k) clearance?

ODONTOSURGE 3 received FDA 510(k) clearance on 2000-08-24, under 510(k) number K001560.

Who is the listed applicant for ODONTOSURGE 3?

The FDA 510(k) record lists Odonto-Wave as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ODONTOSURGE 3?

The FDA product code for ODONTOSURGE 3 is EKZ.

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Related Devices (Code: EKZ)

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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