# K221249: L1P-1F (Trios 5)

- Pathway: 510(k) (Traditional)
- Applicant: 3Shape TRIOS A/S
- Decided: Sep 16, 2022 after 137 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: 4 generations back to DEN990002 (2000). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150672: VistaCam iX Proof, Durr Dental AG (2016) Summary page 5.

## Most influential descendants
- K242103: TRIOS Ready Tip (2025), 0 descendants of its own

## Indications for use
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.

Source page: https://510kreport.com/device/K221249
Methodology: https://510kreport.com/methodology