FDA 510(k) Application Details - K990779

Device Classification Name Varnish, Cavity

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510(K) Number K990779
Device Name Varnish, Cavity
Applicant ADVANTAGE DENTAL PRODUCTS, INC.
4498 KLAIS DR.
CLARKSTON, MI 48348 US
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Contact INGRID K PELERIN
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Regulation Number 872.3260

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Classification Product Code LBH
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Date Received 03/09/1999
Decision Date 11/17/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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