# K173961: Straumann BLX Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Jun 5, 2018 after 159 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: 15 generations back to K960026 (1996). 120 ancestors in all.
15 later devices descend from it; 5 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150182: Neodent Implant System- CM Drive Implants, Jjgc Industria E Comercio DE Materiais Dentarios S (2015) Summary page 5.

## Most influential descendants
- K181703: Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments (2018), 5 descendants of its own
- K200586: Straumann TLX Implant System (2020), 4 descendants of its own
- K192401: Straumann Screw-Retained Abutments (2020), 2 descendants of its own
- K221315: UNIdental Symphony Implant System (2023), 1 descendant of its own
- K220751: Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA (2022), 1 descendant of its own

## Indications for use
Straumann® BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX Implants can be placed with immediate function on single-tooth applications 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. Straumann® Closure Caps and Healing Abutments 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 shape, maintain and stabilize the soft tissue during the healing process. Closure caps and healing abutments should be used only with suitable implant connections. Straumann Closure Caps and Healing Abutments have a maximum duration of usage of 6 months. Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components 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. Final abutments may be placed into occlusion when the implant is fully osseointegrated. BLX Temporary Abutments have a maximum duration of usage of 180 days. Straumann® Variobase® prosthetic components directly or indirectly 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.

Source page: https://510kreport.com/device/K173961
Methodology: https://510kreport.com/methodology