# K181703: Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Dec 28, 2018 after 184 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.
5 later devices descend from it; 4 cite it directly.
0 of 127 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 4.

## Most influential descendants
- K192401: Straumann Screw-Retained Abutments (2020), 2 descendants of its own
- K230104: Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL (2023), 0 descendants of its own
- K210855: Straumann BLX Implant System (2021), 0 descendants of its own
- K201681: Straumann Immediate Temporary Abutments (2021), 0 descendants of its own
- K191256: Straumann BLX Ø3.5 mm Implants (2019), 0 descendants 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, bar and bridge 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. 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.

Source page: https://510kreport.com/device/K181703
Methodology: https://510kreport.com/methodology