# K121685: Soprocare

- Pathway: 510(k) (Traditional)
- Applicant: Sopro
- Decided: Mar 12, 2013 after 278 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: 3 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)
- K092583: Soprolife, Sopro (2010) Summary page 2.
- (no number) GC Tri Plaque ID Gel: named in the summary without a submission number
- (no number) AESCULAP AG Periodontic probe: named in the summary without a submission number

## Most influential descendants
- K223470: C50 (2023), 0 descendants of its own

## Indications for use
The New Device is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflaminationis (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details invibe to the naked eye or with a mirror (thanks to its magnification).

Source page: https://510kreport.com/device/K121685
Methodology: https://510kreport.com/methodology