FDA 510(k) Application Details - K170588

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K170588
Device Name Abutment, Implant, Dental, Endosseous
Applicant Terrats Medical SL
Avenida La Ferreria (Pol Ind Ferreria) 62
Montcada i Reixac 08110 ES
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Contact Roger Terrats
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 02/28/2017
Decision Date 08/08/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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