# K151324: Straumann Variobase for CEREC

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA, LLC
- Decided: Sep 11, 2015 after 116 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: 15 generations back to K894844 (1990). 188 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 202 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142890: Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit, Straumann USA, LLC (2015) Summary page 4.

## Most influential descendants
- K171532: TruBase S (2018), 7 descendants of its own
- K201197: TruAbutment DS, TruBase S (2021), 6 descendants of its own
- K202579: TruAbutment DS, TruBase (2021), 4 descendants of its own
- K203649: TruAbutment DS, TruBase (2021), 3 descendants of its own
- K213961: TruAbutment DS, TruBase (2022), 1 descendant of its own

## Indications for use
The Straumann® Variobase® for CEREC® are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for CEREC® abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® for CEREC® abutments are to be designed using Sirona inLab software (Version 3.65 or higher) or Sirona CEREC Software (Version 4.2 or higher) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

Source page: https://510kreport.com/device/K151324
Methodology: https://510kreport.com/methodology