# K092583: Soprolife

- Pathway: 510(k) (Traditional)
- Applicant: Sopro
- Decided: Jan 13, 2010 after 145 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: 2 generations back to DEN990002 (2000). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040063: Inspektor Pro, Inspektor Dental Care BV (2004) Summary page 2.
- K012505: SOPRO595 Intra Oral Camera, Sopro (2001) Summary page 1.

## Most influential descendants
- K121685: Soprocare (2013), 1 descendant of its own
- K223470: C50 (2023), 0 descendants of its own
- K111423: CS 1600 Intraoral Camera (2012), 0 descendants of its own

## Indications for use
The SOPROLIFE is indicated as an aid in the diagnosis of dental caries and as an intra oral camera to visualize anatomical details Invisible to the naked eye or with mirror.

Source page: https://510kreport.com/device/K092583
Methodology: https://510kreport.com/methodology