FDA 510(k) Application Details - K954827

Device Classification Name Sealant, Pit And Fissure, And Conditioner

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510(K) Number K954827
Device Name Sealant, Pit And Fissure, And Conditioner
Applicant SYBRON DENTAL SPECIALTIES, INC.
1332 SOUTH LONE HILL AVE.
GLENDORA, CA 91740 US
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Contact JEFFREY A ANDERSON
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Regulation Number 872.3765

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Classification Product Code EBC
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Date Received 10/20/1995
Decision Date 01/04/1996
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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