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FDA 510(k) Application Details - K112623
Device Classification Name
Handpiece, Air-Powered, Dental
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510(K) Number
K112623
Device Name
Handpiece, Air-Powered, Dental
Applicant
BEYES DENTAL CANADA INC
3500 SOUTH DUPONT HIGHWAY
DOVER, DE 19901 US
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Contact
ANTHONY HOPKINS
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Regulation Number
872.4200
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Classification Product Code
EFB
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More FDA Info for this Product Code
Date Received
09/08/2011
Decision Date
12/16/2011
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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