# K200597: Straumann BLX Gold Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA, LLC (On Behalf of Institut Straumann Ag)
- Decided: Aug 19, 2020 after 163 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: 16 generations back to K960026 (1996). 127 ancestors in all.
No later device cites it as a predicate yet.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070549: Straumann P.004 RC Gold Abutment, Institut Straumann AG (2007) Summary page 4.
- K072497: P.004 NC Gold Abutment for Crowns, Institut Straumann AG (2007) Summary page 4.
- K071888: Straumann P.004 RC Gold Abutment for Bridges, Straumann USA (2007) Summary page 4.
- K173961: Straumann BLX Implant System, Institut Straumann AG (2018) Summary page 4.

## Indications for use
Straumann abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges, and overdentures.

Source page: https://510kreport.com/device/K200597
Methodology: https://510kreport.com/methodology