FDA 510(k) Application Details - K962192

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K962192
Device Name Material, Tooth Shade, Resin
Applicant SUNRISE TECHNOLOGIES, INC.
47257 FREMONT BLVD.
FREMONT, CA 94538 US
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Contact CAROL KIM
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Regulation Number 872.3690

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Classification Product Code EBF
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Date Received 06/07/1996
Decision Date 09/03/1996
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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