# K200586: Straumann TLX Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Aug 20, 2020 after 167 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: 16 generations back to K960026 (1996). 121 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173961: Straumann BLX Implant System, Institut Straumann AG (2018) Summary page 6.

## Most influential descendants
- K221315: UNIdental Symphony Implant System (2023), 1 descendant of its own
- K262207: Cemented Plus Abutment (2026), 0 descendants of its own
- K243278: Custom Abutments (2025), 0 descendants of its own
- K222836: Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs (2023), 0 descendants of its own

## Indications for use
TLX Dental Implant: Straumann TLX Implants are suitable for endosteal implantation in the upper and lower jaws and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. TLX Implants can be placed with immediate function on single-tooth and multi-unit restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components. TLX Closure Caps and Healing Caps: Straumann Closure Caps and Healing Caps are indicated to be placed in the patient’s mouth at the end of the implant placement to protect the inner configuration of the implant and to form, maintain and stabilize the soft tissue during the healing process. Closure caps and healing caps should be used only with suitable implant connections. They have a maximum duration of usage of 6 months. TLX Temporary Abutment: TLX Temporary Abutments can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. TLX Temporary Abutments have a maximum duration of usage of 180 days. TLX Variobase for Crown: Straumann Variobase prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann Variobase prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. TLX CARES Abutment TAN: The Straumann CARES Abutments TAN are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented. TLX Screw-retained Bridges and Bars: CARES Screw-retained Bridges and Bars (SRBB) are indicated for use as bars and bridges that attach to implants to provide support for prosthetic reconstructions such as bridges and overdentures. The final processed products have the purpose of restoring chewing function. Straumann CARES Screw-retained Bridges and Bars are indicated for Screw-retained restorations. Straumann CARES Screw-retained Bridges and Bars are designed to interface with the Bone Level (BL), Tissue Level (TL), BLX implants and TLX implants of the Straumann Dental Implant System (SDIS).

Source page: https://510kreport.com/device/K200586
Methodology: https://510kreport.com/methodology