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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 K222984
Device Name BioClean Implant Restorative System
Applicant
BioClean Dental, LLC
6088 Eagles Nest Drive
Jupiter,  FL  33458
Applicant Contact Russ Bonafede
Correspondent
PaxMed International, LLC
12264 EL Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact Melissa Burbage
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/28/2022
Decision Date 12/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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