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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 K122300
Device Name T3 DENTAL IMPLANT
Original Applicant
BIOMET 3I
4555 riverside dr.
palm bch gdns,  FL  33410
Original Contact tamara west
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/31/2012
Decision Date 01/30/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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