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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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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