# K242103: TRIOS Ready Tip

- Pathway: 510(k) (Traditional)
- Applicant: 3Shape TRIOS A/S
- Decided: Apr 4, 2025 after 260 days
- Product code: NBL (Light-Induced Fluorescence Caries Detector )
- Device class: 2
- Regulation: 21 CFR 872.1745
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN990002 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221249: L1P-1F (Trios 5), 3Shape TRIOS A/S (2022) Summary page 5.

## Indications for use
The Li P-1 F intraoral scanner (lOS) system is intended for aid in diagnosis of caries.

Source page: https://510kreport.com/device/K242103
Methodology: https://510kreport.com/methodology