# K000213: Jeldent Basic Line

- Pathway: 510(k) (Traditional)
- Applicant: J.F. Jelenko & Co.
- Decided: Apr 6, 2000 after 73 days
- Product code: ELM (Denture, Plastic, Teeth)
- Device class: 2
- Regulation: 21 CFR 872.3590
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K033628: ARTIC (2004), 4 descendants of its own
- K060507: Valplast Yamahachi Teeth (2006), 3 descendants of its own
- K070591: Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic Teeth (2007), 2 descendants of its own
- K101029: Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer Teeth (2010), 1 descendant of its own
- K122955: Dentavit, Monarch, Acrotone, Senator, Dentorium (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K000213
Methodology: https://510kreport.com/methodology