FDA 510(k) Application Details - K242064

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K242064
Device Name Abutment, Implant, Dental, Endosseous
Applicant Smart Denture Conversions, LLC
1800 N Salem Street
Suite 104
Apex, NC 27523 US
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Contact Derrik Conrad
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 07/15/2024
Decision Date 01/17/2025
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242064


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