# K143655: Sicat Optimotion

- Pathway: 510(k) (Traditional)
- Applicant: Sicat GmbH & Co. KG
- Decided: Oct 2, 2015 after 283 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Protection of teeth and restorations from injury due to bruxism. Temporary relief of Temporal Mandibular Disorder (TMD) and bruxism by reducing muscle tension. Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.

Source page: https://510kreport.com/device/K143655
Methodology: https://510kreport.com/methodology