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FDA 510(k) Application Details - K010291
Device Classification Name
Implant, Endosseous, Root-Form
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510(K) Number
K010291
Device Name
Implant, Endosseous, Root-Form
Applicant
STRAUMANN USA
RESERVOIR PLACE,
1601 TRAPELO ROAD
WALTHAM, MA 02154 US
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Contact
LINDA JALBERT
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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
01/31/2001
Decision Date
05/10/2001
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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