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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 K151608
Device Name 4plus6Line Abutment System
Applicant
OT MEDICAL GMBH
KONSUL-SMIDT-STR. 8B
BREMEN,  DE D-28217
Applicant Contact Martina Behlau
Correspondent
OT MEDICAL GMBH
KONSUL-SMIDT-STR. 8B
BREMEN,  DE D-28217
Correspondent Contact Martina Behlau
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/15/2015
Decision Date 04/13/2016
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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