510(k) K891328

PREFORMED TEMPLATE FOR TOOTH POSITIONER by American Orthodontics — Product Code KMY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1989
Date Received
March 10, 1989
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