# K213576: Tatum Surgical Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Suncoast Dental, Inc. Dba Tatum Surgical
- Decided: Jul 15, 2022 after 247 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K960026 (1996). 221 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 223 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133510: Neodent Implant System, Jj Industria E Comercio DE Materiais Dentarios SA (2014) Summary page 4.
- K102034: Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC (2011) Summary page 4.
- K180282: MIS Internal Hex Dental Implant System, Mis Implants Technologies, Ltd. (2018) Summary page 4.
- K122231: Xpeed Any Ridge Internal Implant System, Megagen Implant Co., Ltd. (2012) Summary page 5.
- K061410: Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant System,AV;Zimmer One-Piece Implant, Zimmer Dental, Inc. (2006) Summary page 5.
- K111581: 15 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment Nobelactive 03.0 3MM, 15 Esthetic Abutment Nobelactive, Nobel Biocare AB (2011) Summary page 5.
- K092035: Bicon Implants with a 2.5MM Internal Connection, Bicon, LLC (2009) Summary page 5.
- K171728: MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm, Sterngold Dental, LLC (2017) Summary page 5.
- K071235: Zimmer One Piece Implant, 3.0MM Angled, Models ZOP30A10, ZOP30A11 and ZOP30A13, Zimmer Dental, Inc. (2007) Summary page 5.
- K063523: Zimmer One Piece Implant, 3.7MM and 4.7MM, Models ZOP37S10, 11, 13, 16; ZOP37A10, 11, 13, 16; ZOP47S10, 11, 13, 16; ZOP4, Zimmer Dental, Inc. (2007) Summary page 5.
- K052997: Zimmer Dental One-Piece Implant, Zimmer Dental, Inc. (2006) Summary page 5.
- K093595: Ceraroot Implant System, Oral Iceberg S.L. (2011) Summary page 5.
- K110548: Osi O-Ball Abutment Head Implants, Juell Dental (2011) Summary page 5.

## Most influential descendants
- K254145: Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (2026), 0 descendants of its own

## Indications for 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 unit 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.

Source page: https://510kreport.com/device/K213576
Methodology: https://510kreport.com/methodology