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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 K221019
Device Name Osteon Precision Milled Suprastructure
Applicant
Implant Solutions Pty Ltd (Aka Osteon Medical)
759-767 Springvale Rd.
Mulgrave,  AU 3170
Applicant Contact Andrea Del Ciotto
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 Received04/06/2022
Decision Date 07/05/2022
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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