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KMY — Positioner, Tooth, Preformed Class I

FDA Device Classification

Classification Details

Product Code
KMY
Device Class
Class I
Regulation Number
872.5525
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K931615ortho-tainNITE-GUIDEApril 14, 1995
K942667dentauraumDENT-O-CRYL ORTHODONTIC ACRYLICFebruary 13, 1995
K924351glenroe technologiesGLENROE ELASTIBITE STIMULATORJanuary 6, 1994
K925064aquatemp service coRELAX-O-GUARDSeptember 13, 1993
K924975myofunctional research corp. pty.THE ORTHOTRAINERJuly 8, 1993
K924974myofunctional research corp. pty.THE TMJ APPLIANCEJune 23, 1993
K904128american orthodonticsPERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONERNovember 9, 1990
K891328american orthodonticsPREFORMED TEMPLATE FOR TOOTH POSITIONERMarch 31, 1989
K833455jeffrey h. attlinREMOLDABLE CRANIOMANDIBULAR APPLIANCEJanuary 10, 1984
K831793martin d. lermanAQUALIZER MOUTHPIECEAugust 12, 1983
K821458dynamic functional positionerDYNAMIC FUNTIONAL POSITIONERJune 9, 1982
K780619tp laboratoriesPREFORMED TOOTH POSITIONERJune 28, 1978