FDA 510(k) Application Details - K203660

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K203660
Device Name Implant, Endosseous, Root-Form
Applicant TRI Dental Implants Int. AG
Boesch 80A / Postfach 419
Huenenberg 6331 CH
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Contact Sandro Venanzoni
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 12/15/2020
Decision Date 12/21/2021
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 K203660


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