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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 K213106
Device Name BTI Interna Dental Implant System UnicCa - Prosthetic Components
Applicant
B.T.I. Biotechnology Institute, SL.
Leonardo Da Vinci 14, Parque Technologico de Alava
Minano,  ES 01510
Applicant Contact Jose Ramon Rivero
Correspondent
B.T.I. Biotechnology Institute, SL.
Leonardo Da Vinci 14, Parque Technologico de Alava
Minano,  ES 01510
Correspondent Contact Jose Ramon Rivero
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/24/2021
Decision Date 10/20/2022
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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