# K221107: TRUST

- Pathway: 510(k) (Traditional)
- Applicant: Rgorithm Korea
- Decided: Jul 18, 2023 after 459 days
- Product code: PNP (Dental Abutment Design Software For Dental Laboratory)
- 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: 12 generations back to K894844 (1990). 118 ancestors in all.
No later device cites it as a predicate yet.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200100: Abutment Design, 3Shape A/S (2020) Summary page 4.

## Indications for use
TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxillae. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

Source page: https://510kreport.com/device/K221107
Methodology: https://510kreport.com/methodology