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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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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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