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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 K111216
Device Name OSSEOTITE 2 DENTAL IMPLANTS
Applicant
Biomet 3i, Inc.
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Applicant Contact MARTHA I GARAY
Correspondent
Biomet 3i, Inc.
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Correspondent Contact MARTHA I GARAY
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/02/2011
Decision Date 11/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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