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510(k) K924974

THE TMJ APPLIANCE by Myofunctional Research Corp. Pty. , Ltd. — Product Code KMY

K924974 is an FDA 510(k) premarket notification submitted by Myofunctional Research Corp. Pty. , Ltd. for the device "THE TMJ APPLIANCE". The FDA issued a decision of SN on June 23, 1993. The device falls under product code KMY (Positioner, Tooth, Preformed), a Class I device regulated under 21 CFR 872.5525. Myofunctional Research Corp. Pty. , Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SN ()
Decision Date
June 23, 1993
Date Received
September 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Positioner, Tooth, Preformed
Device Class
Class I
Regulation Number
872.5525
Review Panel
DE
Submission Type

Other clearances by Myofunctional Research Corp. Pty. , Ltd.

  • K924975 — THE ORTHOTRAINER (July 8, 1993)

Other clearances for product code KMY

  • K931615 — NITE-GUIDE (April 14, 1995)
  • K942667 — DENT-O-CRYL ORTHODONTIC ACRYLIC (February 13, 1995)
  • K924351 — GLENROE ELASTIBITE STIMULATOR (January 6, 1994)
  • K925064 — RELAX-O-GUARD (September 13, 1993)
  • K924975 — THE ORTHOTRAINER (July 8, 1993)
  • K904128 — PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER (November 9, 1990)
  • K891328 — PREFORMED TEMPLATE FOR TOOTH POSITIONER (March 31, 1989)
  • K833455 — REMOLDABLE CRANIOMANDIBULAR APPLIANCE (January 10, 1984)
  • K831793 — AQUALIZER MOUTHPIECE (August 12, 1983)
  • K821458 — DYNAMIC FUNTIONAL POSITIONER (June 9, 1982)

FDA data resources