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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 K072363
Device Name NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX
Applicant
Biomet 3i, Inc.
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Applicant Contact DIANA TAYLOR
Correspondent
Biomet 3i, Inc.
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Correspondent Contact DIANA TAYLOR
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/23/2007
Decision Date 01/31/2008
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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