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FDA 510(k) Application Details - K972769
Device Classification Name
Implant, Endosseous, Root-Form
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510(K) Number
K972769
Device Name
Implant, Endosseous, Root-Form
Applicant
OPTI-MAX
6281 OAK BAY RD.
PORT LUDLOW, WA 98365 US
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Contact
WILLIAM F ZINGHEIM
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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
07/24/1997
Decision Date
11/13/1997
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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