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FDA 510(k) Application Details - K052040
Device Classification Name
Heat Source For Bleaching Teeth
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510(K) Number
K052040
Device Name
Heat Source For Bleaching Teeth
Applicant
COSMETIC DENTAL MATERIALS INC
812 WATER ST. N.E.
ALBANY, OR 97321 US
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ROBERT BOWERS
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Regulation Number
872.6475
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Classification Product Code
EEG
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More FDA Info for this Product Code
Date Received
07/28/2005
Decision Date
10/18/2005
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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