Tatum Surgical Dental Implant System

Implant, Endosseous, Root-form

Suncoast Dental, Inc. Dba Tatum Surgical

The following data is part of a premarket notification filed by Suncoast Dental, Inc. Dba Tatum Surgical with the FDA for Tatum Surgical Dental Implant System.

Pre-market Notification Details

Device IDK213576
510k NumberK213576
Device Name:Tatum Surgical Dental Implant System
ClassificationImplant, Endosseous, Root-form
Applicant Suncoast Dental, Inc. Dba Tatum Surgical 4500 140th Avenue North Suite 112 Clearwater,  FL  33762
ContactTony Fiorello
CorrespondentMelissa Burbage
PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego,  CA  92130
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-10
Decision Date2022-07-15

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.