# K203355: Straumann TLX Novaloc and Cementable Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Feb 12, 2021 after 88 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: 2 generations back to K190040 (2019). 2 ancestors in all.
2 later devices descend 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)
- K193046: Straumann® Retentive System – Novaloc TiN Abutments, Institut Straumann AG (2020) Summary page 5.

## Most influential descendants
- K213063: TLX SRAs and TLX Gold Abutments (2022), 1 descendant of its own
- K231566: ICX-Implant System (2024), 0 descendants of its own

## Indications for use
The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants (NT, RT, and WT). Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Final abutments may be placed into occlusion for implants with sufficient primary stability and with appropriate occlusal loading to restore chewing function or for implants that are fully osseointegrated.

Source page: https://510kreport.com/device/K203355
Methodology: https://510kreport.com/methodology