FDA 510(k) Application Details - K981997

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K981997
Device Name Implant, Endosseous, Root-Form
Applicant THE DENTAL MEDICAL DEVICE CO., L.L.C.
39 AYNSLEY CT.
MONTVILLE, NJ 07045 US
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Contact MARCI BLOOM
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 06/08/1998
Decision Date 01/12/1999
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

FDA Source Information for K981997


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