# K192401: Straumann Screw-Retained Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA, LLC
- Decided: Apr 6, 2020 after 216 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
Longest line of descent: 17 generations back to K960026 (1996). 140 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 143 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.
- K171757: Straumann Screw Retained Abutments, Straumann USA, LLC (On Behalf of Institut Straumann Ag) (2017) Summary page 4.
- K133421: Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw, Straumann USA, LLC (2014) Summary page 4.

## Most influential descendants
- K230104: Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL (2023), 0 descendants of its own
- K201681: Straumann Immediate Temporary Abutments (2021), 0 descendants of its own

## Indications for use
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 are to be placed out of occlusion. Final abutments may be placed into occlusion for implants with sufficient primary stability or for implants that are fully osseointegrated. Temporary Abutments have a maximum duration of usage of 180 days.

Source page: https://510kreport.com/device/K192401
Methodology: https://510kreport.com/methodology