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FDA 510(k) Application Details - K973185
Device Classification Name
Agent, Tooth Bonding, Resin
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510(K) Number
K973185
Device Name
Agent, Tooth Bonding, Resin
Applicant
AMERICAN DENTAL PRODUCTS, INC.
22 W 246 SUNNYSIDE RD.
MEDINAH, IL 60157-9705 US
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Contact
GEORGE NICOLAE
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Regulation Number
872.3200
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Classification Product Code
KLE
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More FDA Info for this Product Code
Date Received
08/25/1997
Decision Date
11/14/1997
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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