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FDA 510(k)

THE ORTHOTRAINER

K-Number: K924975 · 1993-07-08

ApplicantMyofunctional Research Corp. Pty. , Ltd.
Decision Date1993-07-08
Product CodeKMY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE ORTHOTRAINER is the device name listed in this FDA 510(k) record. The listed applicant is Myofunctional Research Corp. Pty. , Ltd.. It received FDA 510(k) clearance on 1993-07-08 under 510(k) number K924975. The device is classified under product code KMY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE ORTHOTRAINER?

THE ORTHOTRAINER is a medical device that received FDA 510(k) clearance on 1993-07-08. The listed applicant is Myofunctional Research Corp. Pty. , Ltd.. The 510(k) number is K924975.

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

THE ORTHOTRAINER received FDA 510(k) clearance on 1993-07-08, under 510(k) number K924975.

Who is the listed applicant for THE ORTHOTRAINER?

The FDA 510(k) record lists Myofunctional Research Corp. Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE ORTHOTRAINER?

The FDA product code for THE ORTHOTRAINER is KMY.

Related Clinical Trials

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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Other records listing Myofunctional Research Corp. Pty. , Ltd. as applicant

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.

K924974THE TMJ APPLIANCE

Related Devices (Code: KMY)

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.

K931615NITE-GUIDEORTHO-TAIN, Inc.K942667DENT-O-CRYL ORTHODONTIC ACRYLICDentauraum, Inc.K924351GLENROE ELASTIBITE STIMULATORGlenroe TechnologiesK925064RELAX-O-GUARDAquatemp Service Co., Inc.K924974THE TMJ APPLIANCEMyofunctional Research Corp. Pty. , Ltd.K904128PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONERAmerican Orthodontics

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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