# K163228: APVolution System

- Pathway: 510(k) (Abbreviated)
- Applicant: Aesthetic-Press, LLC
- Decided: Jun 5, 2017 after 200 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K024250 (2003). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141400: Dcceram System, Ceramay GmbH & Co.Kg (2015) Summary page 4.

## Indications for use
The APVolution System is used to fabricate prostheses for missing/damaged teeth. The APVolution pressable ingots are pressed onto metal alloy (APVolution M) or zirconia (APVolution Z) frames by dental technicians to fabricate ceramic restorations. APVolution M and APVolution Z ceramic layering powders and/or pastes are used to layer or build up the pressed ceramic to final tooth morphology. APVolution S ceramic ingots are used to create all-ceramic restorations. AP Stains and Glaze are used during the fabrication process to achieve the correct shade.

Source page: https://510kreport.com/device/K163228
Methodology: https://510kreport.com/methodology