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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K183518
Device Name Preat Abutments
Applicant
Preat Corporation
100 S. 4th Street
Grover Beach,  CA  93433
Applicant Contact Chris Bormes
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin A. Thomas
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
DZE  
Date Received12/18/2018
Decision Date 03/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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