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FDA 510(k)

Tatum Surgical Dental Implant System

K-Number: K213576 · 2022-07-15

ApplicantSuncoast Dental, Inc. Dba Tatum Surgical
Decision Date2022-07-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Tatum Surgical Dental Implant System is a medical device manufactured by Suncoast Dental, Inc. Dba Tatum Surgical. It received FDA 510(k) clearance on 2022-07-15 under approval number K213576. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tatum Surgical Dental Implant System?

Tatum Surgical Dental Implant System is a medical device that received FDA 510(k) clearance on 2022-07-15. It is manufactured by Suncoast Dental, Inc. Dba Tatum Surgical. The 510(k) number is K213576.

When was Tatum Surgical Dental Implant System approved by the FDA?

Tatum Surgical Dental Implant System received FDA 510(k) clearance on 2022-07-15, under approval number K213576.

What company makes Tatum Surgical Dental Implant System?

Tatum Surgical Dental Implant System is manufactured by Suncoast Dental, Inc. Dba Tatum Surgical.

What is the FDA product code for Tatum Surgical Dental Implant System?

The FDA product code for Tatum Surgical Dental Implant System is DZE.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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