# K173945: Straumann SC Variobase Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Oct 5, 2018 after 283 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). 263 ancestors in all.
No later device cites it as a predicate yet.
0 of 264 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 4.
- K170356: Straumann Variobase Abutments, Institut Straumann AG (2017) Summary page 4.

## Indications for use
Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

Source page: https://510kreport.com/device/K173945
Methodology: https://510kreport.com/methodology