# K213063: TLX SRAs and TLX Gold Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Apr 8, 2022 after 197 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: 3 generations back to K190040 (2019). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203355: Straumann TLX Novaloc and Cementable Abutments, Institut Straumann AG (2021) Summary page 5.

## Most influential descendants
- K231566: ICX-Implant System (2024), 0 descendants of its own

## Indications for use
TLX SRAs Straumann® abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of edentulous or partially edentulous patients with crowns, bridges or full-arch prostheses. TLX Gold Abutments Straumann® abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of edentulous or partially edentulous patients with crowns, bridges or full-arch prostheses. Copings are indirectly connected to the endosseous dental implant and are indicated for use as an aid in prosthetic rehabilitations.

Source page: https://510kreport.com/device/K213063
Methodology: https://510kreport.com/methodology