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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 K142211
Device Name OT EQUATOR
Rhein '83 SRL
Via Emilio Zago, 10/abc
Bologna,  IT 40128
Applicant Contact Claudia Nardi
Rhein '83 SRL
Via Emilio Zago, 10/abc
Bologna,  IT 40128
Correspondent Contact Claudia Nardi
Regulation Number872.3630
Classification Product Code
Date Received08/12/2014
Decision Date 11/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No