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510(k) Data Aggregation
K Number
K213576Device Name
Tatum Surgical Dental Implant System
Manufacturer
Date Cleared
2022-07-15
(247 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Suncoast Dental, Inc. dba Tatum Surgical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Tatum Surgical Integrity Tapered, "T" and "S" Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prothesis to restore chewing function. It may be used with single-stage or two- stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
The Tatum Surgical Dental "P" Plateau Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing function. It may be used for single or multiple unit restorations and is indicated for delayed loading, placed with conventional two-stage surgical process with secondary and transmucosal healing.
The Tatum Surgical One-Piece Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing function. It may be used for single or multiple unt restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The 3.0 mm diameter Tatum Surgical One-Piece Implant must be splinted if two or more are used adjacent to each other.
Device Description
The subject device includes three (3) two-piece implant systems that have connections and prosthetic components in multiple designs unique to each system, including straight and angled abutments intended for single-unit and multiple-unit restorations. The subject device also includes one (1) one-piece implant system, in which the abutment portion is integral with the implant portion.
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