# K171532: TruBase S

- Pathway: 510(k) (Traditional)
- Applicant: Truabutment, Inc.
- Decided: Sep 11, 2018 after 474 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). 189 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 197 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151324: Straumann Variobase for CEREC, Straumann USA, LLC (2015) Summary page 4.

## Most influential descendants
- 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
- K241485: TruAbutment DS; TruBase (2024), 0 descendants of its own

## Indications for use
The TruBase S is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems: o Zimmer TSV - 3.7, 4.1, 4.7, 6.0 mm (3.5, 4.5, 5.7mm platform sizes) All digitally designed abutments and/or coping for use with the TruBase S are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MCX or MC XL milling unit.

Source page: https://510kreport.com/device/K171532
Methodology: https://510kreport.com/methodology