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FDA 510(k)

THE GNATHOMETER

K-Number: K033092 · 2004-04-21

ApplicantOrtho Gnathics, LLC
Decision Date2004-04-21
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE GNATHOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Gnathics, LLC. It received FDA 510(k) clearance on 2004-04-21 under 510(k) number K033092. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE GNATHOMETER?

THE GNATHOMETER is a medical device that received FDA 510(k) clearance on 2004-04-21. The listed applicant is Ortho Gnathics, LLC. The 510(k) number is K033092.

When did THE GNATHOMETER receive FDA 510(k) clearance?

THE GNATHOMETER received FDA 510(k) clearance on 2004-04-21, under 510(k) number K033092.

Who is the listed applicant for THE GNATHOMETER?

The FDA 510(k) record lists Ortho Gnathics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE GNATHOMETER?

The FDA product code for THE GNATHOMETER is JEY.

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Related Devices (Code: JEY)

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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