FDA 510(k) Application Details - K944962

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K944962
Device Name Implant, Endosseous, Root-Form
Applicant NOBELPHARMA USA, INC.
777 OAKMONT LN.
SUITE 100
WESTMONT, IL US
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Contact MARY EDWARDS
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 10/07/1994
Decision Date 02/27/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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