FDA 510(k) Application Details - K003620

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K003620
Device Name Implant, Endosseous, Root-Form
Applicant NSI
10565 LEE HIGHWAY
SUITE 100
FAIRFAX,, VA 22030 US
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Contact GRETA M HOLS
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 11/22/2000
Decision Date 09/19/2001
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 K003620


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