# K003995: Speculite/Orallite

- Pathway: 510(k) (Traditional)
- Applicant: Trylon Corp.
- Decided: Mar 16, 2001 after 80 days
- Product code: EAZ (Light, Operating, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K060920: Velscope (2006), 12 descendants of its own
- K070523: Modification to: Velscope (2007), 10 descendants of its own
- K033033: Vizilite-Blue Oral Exam Kit (2004), 9 descendants of its own
- K082603: Trimira Ocs 3000 (2008), 8 descendants of its own
- K090135: Trimira Identafi 3000 (2009), 7 descendants of its own

Source page: https://510kreport.com/device/K003995
Methodology: https://510kreport.com/methodology