FDA 510(k) Application Details - K893255

Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin

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510(K) Number K893255
Device Name Adhesive, Bracket And Tooth Conditioner, Resin
Applicant AMERICAN ORTHODONTICS
1714 CAMBRIDGE AVE.
SHEBOYGAN, WI US
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Contact PAUL RIDDLE
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Regulation Number 872.3750

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Classification Product Code DYH
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Date Received 04/28/1989
Decision Date 06/21/1989
Decision SE - Substantially Equivalent
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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