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FDA 510(k) Application Details - K012946
Device Classification Name
Activator, Ultraviolet, For Polymerization
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510(K) Number
K012946
Device Name
Activator, Ultraviolet, For Polymerization
Applicant
KINETIC INSTRUMENTS, INC.
17 BERKSHIRE BLVD.
BETHEL, CT 06801 US
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Contact
WILLIAM J BECKER
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Regulation Number
872.6070
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Classification Product Code
EBZ
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More FDA Info for this Product Code
Date Received
09/04/2001
Decision Date
10/02/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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