FDA 510(k) Application Details - K020171

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K020171
Device Name Activator, Ultraviolet, For Polymerization
Applicant DENTAL SYSTEMS.COM, INC.
1187 TADSWORTH TERRACE
HEATHROW, FL 32746 US
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Contact SHINOBU DOI
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 01/17/2002
Decision Date 01/29/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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