FDA 510(k) Application Details - K000065

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K000065
Device Name Implant, Endosseous, Root-Form
Applicant ALTATEC BIOTECHNOLOGIES
9229 CRANFORD DR.
POTOMAC, MD 20854 US
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Contact R.J. SLOMOFF
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 01/10/2000
Decision Date 01/28/2000
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



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