FDA 510(k) Application Details - K233316

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K233316
Device Name Abutment, Implant, Dental, Endosseous
Applicant Terrats Medical SL
Carrer Mogoda 75-99
Barberα del VallΦs 08210 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 09/29/2023
Decision Date 01/05/2024
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

FDA Source Information for K233316


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