# K241575: Straumann® Anatomic Healing Abutments XC (AHA)

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA, LLC
- Decided: Nov 11, 2024 after 161 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: 11 generations back to K894595 (1990). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130808: Straumann Healing Abutments, Healing Caps, Closure Screws, Straumann USA (2013) Summary page 6.

## Recalls of this device
- Apr 17, 2025 · Class II · Z-1671-2025: Incorrect blister labelling.

## Indications for use
Straumann® Anatomic Healing Abutments are indicated to be placed in partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain and stabilize the soft tissue during the healing process. Healing components have a maximum duration of usage of 180 days.

Source page: https://510kreport.com/device/K241575
Methodology: https://510kreport.com/methodology