FDA 510(k) Application Details - K972890

Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin

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510(K) Number K972890
Device Name Adhesive, Bracket And Tooth Conditioner, Resin
Applicant SYBRON DENTAL SPECIALTIES, INC.
1717 WEST COLLINS AVE.
ORANGE, CA 92867 US
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Contact WILLIAM R PIKE
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Regulation Number 872.3750

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Classification Product Code DYH
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Date Received 08/05/1997
Decision Date 09/16/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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