# K191843: Ceramill A-Temp

- Pathway: 510(k) (Traditional)
- Applicant: Amann Girrbach AG
- Decided: Oct 4, 2019 after 87 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K070991 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112967: Pmma Cad/Cam Disc, Polident D.O.O., Dental Products Industry (2012) Summary page 5.

## Indications for use
- Temporary anterior and posterior crowns with a wearing time of maximum three years - Temporary anterior and posterior bridges with a maximum of two connected pontics and a maximum wearing time of three years - Verifying the fit on the plaster model/mouth before the final restoration

Source page: https://510kreport.com/device/K191843
Methodology: https://510kreport.com/methodology