# K190654: Straumann CI RD Ceramic Healing Caps

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Jun 28, 2019 after 106 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: 7 generations back to K022562 (2002). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180477: Straumann PURE Ceramic Implant System, Institut Straumann AG (2019) Summary page 4.

## Most influential descendants
- K192893: Straumann Ceramic Healing Abutments (2020), 1 descendant of its own
- K232383: iPhysio® System (2025), 0 descendants of its own

## Indications for use
Healing Caps are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Healing Caps should be used only with suitable implant connections. The healing components are intended to be used up to 6 months.

Source page: https://510kreport.com/device/K190654
Methodology: https://510kreport.com/methodology