FDA 510(k) Application Details - K991822

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K991822
Device Name Implant, Endosseous, Root-Form
Applicant DR. IHDE DENTAL AG SWITZERLAND
BATTERY PLACE 70, RIVERWATCH
SUITE 406
NEW YORK, NY 10280 US
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Contact MOURAD BARAKET
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 05/27/1999
Decision Date 08/15/2001
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

FDA Source Information for K991822


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