# K192029: Straumann PUREloc abutments

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Oct 28, 2019 after 90 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: 1 generation back to K190040 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190040: Straumann BLX Line Extension - New Abutments, Institut Straumann AG (2019) Summary page 4.

## Indications for use
The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann implants.

Source page: https://510kreport.com/device/K192029
Methodology: https://510kreport.com/methodology