# K192893: Straumann Ceramic Healing Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Jan 3, 2020 after 84 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: 16 generations back to K894844 (1990). 274 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 276 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190654: Straumann CI RD Ceramic Healing Caps, Institut Straumann AG (2019) Summary page 5.
- K162890: BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment, Straumann USA, LLC (2017) Summary page 5.
- K190662: MRI Compatibility for Existing Straumann Dental Implant Systems, Straumann USA, LLC (2019) Summary page 5.

## Most influential descendants
- K232383: iPhysio® System (2025), 0 descendants of its own

## Indications for use
Straumann® Ceramic Healing abutments are indicated to be placed in the patient’s mouth at the end of the implant placement to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Healing abutments 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/K192893
Methodology: https://510kreport.com/methodology