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FDA 510(k) Application Details - K982129
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K982129
Device Name
Powder, Porcelain
Applicant
EUROPEAN DENTAL IMPORTS, INC.
49 EMERSON RD.
DURHAM, NH 03824-2112 US
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Contact
MICHAEL H EVERNGAM
Other 510(k) Applications for this Contact
Regulation Number
872.6660
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Classification Product Code
EIH
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More FDA Info for this Product Code
Date Received
06/17/1998
Decision Date
08/04/1998
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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