FDA 510(k) Application Details - K981647

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K981647
Device Name Material, Tooth Shade, Resin
Applicant 3M COMPANY
3M CENTER
BLDG. 275-3SE-08
ST. PAUL, MN 55144-1000 US
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Contact LEAL PICKETT
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Regulation Number 872.3690

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Classification Product Code EBF
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Date Received 05/11/1998
Decision Date 08/09/1998
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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