# K243278: Custom Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Feb 21, 2025 after 128 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 1 (0 Class I)
- 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)
- K200586: Straumann TLX Implant System, Institut Straumann AG (2020) Summary page 5.

## Recalls of this device
- Mar 17, 2026 · Class II · Z-1633-2026: A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as 

## Indications for use
The Straumann Custom Abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented.

Source page: https://510kreport.com/device/K243278
Methodology: https://510kreport.com/methodology