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FDA 510(k) Application Details - K050257
Device Classification Name
Implant, Endosseous, Root-Form
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510(K) Number
K050257
Device Name
Implant, Endosseous, Root-Form
Applicant
MONDEAL MEDICAL SYSTEMS GMBH
AMSTEL 320-1
AMSTERDAM 1017AP NL
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Contact
ANGELIKA SCHERP
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Regulation Number
872.3640
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Classification Product Code
DZE
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More FDA Info for this Product Code
Date Received
02/03/2005
Decision Date
02/07/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K050257
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