510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924975Substantially Equivalent

The Orthotrainer

Myofunctional Research Corp. Pty. Ltd., Helensvale, Queensland, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924975 is the FDA 510(k) clearance record for THE ORTHOTRAINER, a class I device, cleared for Myofunctional Research Corp. Pty. , Ltd. on under FDA product code KMY (Positioner, Tooth, Preformed). FDA records list 3 510(k) clearances for Myofunctional Research Corp. Pty. , Ltd., from to . As of , FDA records show no recalls naming K924975.

Clearance record

Decision date
Received
(281 days to decision)
Product code
KMY Positioner, Tooth, Preformed
Regulation
21 CFR 872.5525
Device class
Class I
Review panel
Dental
Applicant
Myofunctional Research Corp. Pty. , Ltd. P.O. Box 14, Helensvale, Queensland, AU
510(k) summary
Statement
Third party review
No

Clearances, product code KMY

Trailing 12 months

FDA records hold no clearances under product code KMY in the trailing twelve months.

FDA records show no clearances under product code KMY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260