# K201842: TruBase S

- Pathway: 510(k) (Traditional)
- Applicant: Truabutment, Inc.
- Decided: Jun 4, 2021 after 333 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: 18 generations back to K894844 (1990). 209 ancestors in all.
No later device cites it as a predicate yet.
0 of 210 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201197: TruAbutment DS, TruBase S, Truabutment, Inc. (2021). Cleared while this submission was under review Summary page 4.

## Indications for use
TruBase S is a titanium component that is directly connected to endosseous dental implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems: * NobelActive (K102436, K071370, K133731): 3.0, 3.5, 4.3, 5.0, 5.5 (3.0, NP, RP, WP) All digitally designed abutments and/or copings for use with TruBase S are intended to be sent to a TruAbutment-validated milling center for manufacture. TruBase S is compatible with the following devices: NobelActive (K102436, K071370, K133731) Implant Body Diameter 3.0 / Implant Platform 3.0 / Connection Type: Internal Hex Implant Body Diameter 3.5 / Implant Platform NP / Connection Type: Internal Hex Implant Body Diameter 4.3 / Implant Platform RP / Connection Type: Internal Hex Implant Body Diameter 5.0 / Implant Platform RP / Connection Type: Internal Hex Implant Body Diameter 5.5 / Implant Platform WP / Connection Type: Internal Hex

Source page: https://510kreport.com/device/K201842
Methodology: https://510kreport.com/methodology