# K191836: Ceramill A-Splint

- Pathway: 510(k) (Traditional)
- Applicant: Amann Girrbach AG
- Decided: Dec 20, 2019 after 164 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
Longest line of descent: 4 generations back to K780619 (1978). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K134015: M-PM-Disc, Merz Dental GmbH (2014) Summary page 5.

## Indications for use
Ceramill A-Splint is indicated for the fabrication of removable bite splints.

Source page: https://510kreport.com/device/K191836
Methodology: https://510kreport.com/methodology