K-number	K891328
Device name	PREFORMED TEMPLATE FOR TOOTH POSITIONER
Applicant	American Orthodontics
Product code	KMY
Device class	Class I
Decision date	Mar 31, 1989
Decision	Substantially Equivalent
Regulation	872.5525

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View the full FDA submission: accessdata.fda.gov

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PREFORMED TEMPLATE FOR TOOTH POSITIONER

Everything you need for a 510(k) submission. Nothing you don't.