# K061337: Wiedent Estetic

- Pathway: 510(k) (Traditional)
- Applicant: Xpdent Corp
- Decided: Jun 7, 2006 after 26 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- 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

## Indications for use
Acrylic teeth to be used for construction of full and partial dentures by a dental professional. Dentures are removable, not implanted in patients' mouths.

Source page: https://510kreport.com/device/K061337
Methodology: https://510kreport.com/methodology