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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K213576
Device Name Tatum Surgical Dental Implant System
Applicant
Suncoast Dental, Inc. Dba Tatum Surgical
4500 140th Ave. N. Suite 112
Clearwater,  FL  33762
Applicant Contact Tony Fiorello
Correspondent
PaxMed International, LLC
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Correspondent Contact Melissa Burbage
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received11/10/2021
Decision Date 07/15/2022
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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