# K191256: Straumann BLX Ø3.5 mm Implants

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Dec 27, 2019 after 231 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: 17 generations back to K960026 (1996). 122 ancestors in all.
No later device cites it as a predicate yet.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181703: Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments, Institut Straumann AG (2018) Summary page 4.

## 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 by the corresponding abutment components.

Source page: https://510kreport.com/device/K191256
Methodology: https://510kreport.com/methodology