# K141400: Dcceram System

- Pathway: 510(k) (Traditional)
- Applicant: Ceramay GmbH & Co.Kg
- Decided: Jan 28, 2015 after 245 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: 4 generations back to K024250 (2003). 11 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111743: The Insync Ceramic System, Jensen Industries, Inc. (2011) Summary page 4.
- K002904: Willi Geller Creation and LF Porcelain, Jensen Industries, Inc. (2000) Summary page 4.
- K994435: Opc 3G All-Ceramic System, Core and Overlay Porcelains, Jeneric/Pentron, Inc. (2000) Summary page 4.

## Most influential descendants
- K192251: Livento Press, Soprano 10, Soprano (2020), 1 descendant of its own
- K251084: zirkon; structure; LFU shades, stains and glazes (2025), 0 descendants of its own
- K163228: APVolution System (2017), 0 descendants of its own

## Indications for use
The DCceram System is used to fabricate prostheses for missing/damaged teeth. The DCceram pressable ceramic ingots are pressed onto metal alloy (DCceram 12.5) or zirconia (DCceram 9.2) frames by dental technicians to fabricate ceramic restorations. DCceram 12.5 and DCceram 9.2 ceramic layering porcelains and shades are used to layer or build up the pressed ceramic to final tooth morphology and shade on the particular framework (DCceram 9.2 zirconia substructures: Deceram 12.5 metal substructures). The DCceram conceptPress ceramic ingots are used to fabricate all-ceramic restorations. DCceram conceptArt ceramic stains and shades may be used with DCceram conceptPress or DCeeram 9.2 ceramics.

Source page: https://510kreport.com/device/K141400
Methodology: https://510kreport.com/methodology