FDA 510(k) Application Details - K231132

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K231132
Device Name Abutment, Implant, Dental, Endosseous
Applicant J & P Dental Technologies
1309 S Adams St
Fort Worth, TX 76104 US
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Contact Babak Aaron Paz
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 04/21/2023
Decision Date 03/26/2024
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 K231132


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