# K161677: Straumann Sterile Healing Solution

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Oct 7, 2016 after 112 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: 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 4.

## Indications for use
Healing abutments, healing caps and closure screws are intended for use with the implants of the Straumann Dental Implant System to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Fixation caps are used to stabilize bone grafts in cases where bone augmentation is being performed in conjunction with implant placement.

Source page: https://510kreport.com/device/K161677
Methodology: https://510kreport.com/methodology