FDA 510(k) Application Details - K130183

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K130183
Device Name Abutment, Implant, Dental, Endosseous
Applicant STERNGOLD DENTAL LLC
23 FRANK MOSSBERG DRIVE
ATTLEBORO, MA 02703 US
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Contact MARIA RAO
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 01/25/2013
Decision Date 07/07/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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