FDA 510(k) Application Details - K243272

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K243272
Device Name Abutment, Implant, Dental, Endosseous
Applicant Zest Anchors, LLC
2875 Loker Ave E
Carlsbad, CA 92010 US
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Contact David Lin
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 10/16/2024
Decision Date 01/14/2025
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 K243272


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