# K222836: Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: May 15, 2023 after 237 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K960026 (1996). 262 ancestors in all.
No later device cites it as a predicate yet.
0 of 263 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST, Institut Straumann AG (2012) Summary page 6.
- K170356: Straumann Variobase Abutments, Institut Straumann AG (2017) Summary page 6.
- K190082: Straumann BLX Variobase Abutment, Institut Straumann AG (2019) Summary page 6.
- K200586: Straumann TLX Implant System, Institut Straumann AG (2020) Summary page 6.
- K072569: Metoxit Cam-Blanks, Metoxit AG (2007) Summary page 6.
- K170050: Z-CAD smile, Metoxit AG (2018) Summary page 6.

## Recalls of this device
- Mar 27, 2026 · Class II · Z-1995-2026: Includes an incorrect screw seat interface.

## Indications for use
The Straumann® Variobase® abutments are prosthetic components placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® abutments are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations. 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. Temporary restorations are indicated to be placed out of occlusion. 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 manufacturing by a validated milling center. Once finalized into a suitable design: n!ce® Zirconia LT and n!ce® Zirconia HT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to full arch. n!ce® Zirconia XT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to 3 units.

Source page: https://510kreport.com/device/K222836
Methodology: https://510kreport.com/methodology