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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K130216
Device Name ATLANTIS STRAUMANN BONE LEVEL ABUTMENT
Applicant
DENTSPLY IMPLANT
12264 EL CAMINO REAL
SUITE 400
SAN DIEGO,  CA  92130
Applicant Contact LINDA K SCHULZ
Correspondent
DENTSPLY IMPLANT
12264 EL CAMINO REAL
SUITE 400
SAN DIEGO,  CA  92130
Correspondent Contact LINDA K SCHULZ
Regulation Number872.3630
Classification Product Code
NHA  
Date Received01/29/2013
Decision Date 05/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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