FDA 510(k) Application Details - K010619

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K010619
Device Name Implant, Endosseous, Root-Form
Applicant DIAMODENT
2737 EAST REGAL PARK AVE.
ANAHEIM, CA 92806 US
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Contact JEFF RASSOLI
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 03/01/2001
Decision Date 09/28/2001
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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