# K111828: Clearsplint ES

- Pathway: 510(k) (Traditional)
- Applicant: Astron Dental Corporation
- Decided: Oct 26, 2011 after 120 days
- Product code: MQC (Mouthguard, Prescription)
- Device class: U
- 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
- K212017: Thermeo System (2022), 1 descendant of its own
- K260031: Thermeo® I Msi (2026), 0 descendants of its own
- K251252: NOBILCAM IMPAK Disc (2025), 0 descendants of its own

## Indications for use
Clearsplint ES is a heat cured, moldable, acrylic compound for use in the fabrication of dental appliances and dental prostheses devices including TMJ splint appliances, night guards, bruxism appliances and other devices as prescribed.

Source page: https://510kreport.com/device/K111828
Methodology: https://510kreport.com/methodology