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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K130949
Device Name CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS
Applicant
Biomet 3i
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Applicant Contact LAURA HOSHUE
Correspondent
Biomet 3i
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Correspondent Contact LAURA HOSHUE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/05/2013
Decision Date 07/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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