# K111465: Compothixo

- Pathway: 510(k) (Traditional)
- Applicant: Kerrhawe SA
- Decided: Jul 25, 2012 after 426 days
- Product code: DZN (Instruments, Dental Hand)
- Device class: 1
- Regulation: 21 CFR 872.4565
- 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. The FDA summary names its predicate without a number.
- (no number) Hu-Friedy Composite Instrument: named in the summary without a submission number

## Indications for use
The Compothixo is a vibration instrument intended for composite modeling by dental professionals.

Source page: https://510kreport.com/device/K111465
Methodology: https://510kreport.com/methodology