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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 K150571
Device Name 3i T3 Short Implants
Applicant
Biomet 3i
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Applicant Contact CHRIS MCKEE
Correspondent
Biomet 3i
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Correspondent Contact CHRIS MCKEE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received03/06/2015
Decision Date 11/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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