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FDA 510(k) Application Details - K984201
Device Classification Name
Powder, Porcelain
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510(K) Number
K984201
Device Name
Powder, Porcelain
Applicant
DENTRONIC AB
BOX 733
931 27 SKELLETTEA 931 27 SE
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Contact
ANDERS SUNDH
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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
11/24/1998
Decision Date
09/29/1999
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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