# K012505: SOPRO595 Intra Oral Camera

- Pathway: 510(k) (Traditional)
- Applicant: Sopro
- Decided: Oct 5, 2001 after 63 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Air Techniques: named in the summary without a submission number
- (no number) Cygnus: named in the summary without a submission number
- (no number) Schick: named in the summary without a submission number

## Most influential descendants
- K092583: Soprolife (2010), 3 descendants of its own
- 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
Allow intraoral examination and documentation

Source page: https://510kreport.com/device/K012505
Methodology: https://510kreport.com/methodology