# K190040: Straumann BLX Line Extension - New Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Apr 8, 2019 after 90 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K193046: Straumann® Retentive System – Novaloc TiN Abutments (2020), 3 descendants of its own
- K203355: Straumann TLX Novaloc and Cementable Abutments (2021), 2 descendants of its own
- K213063: TLX SRAs and TLX Gold Abutments (2022), 1 descendant of its own
- K253315: Straumann Variobase Abutments XC for Bridge/Bar (2026), 0 descendants of its own
- K231566: ICX-Implant System (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K190040
Methodology: https://510kreport.com/methodology