# K081186: Concave RN Healing Cap

- Pathway: 510(k) (Special)
- Applicant: Institut Straumann AG
- Decided: May 23, 2008 after 25 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 K960634 (1996). 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)
- K960634: Titanium Healing Caps, The Straumann Co. (1996) Summary page 1.

## Indications for use
Healing Caps are intended for placement onto dental implants to protect the inner configuration and shoulder of the implant and to maintain, stabilize and form the soft tissue during the healing phase.

Source page: https://510kreport.com/device/K081186
Methodology: https://510kreport.com/methodology