# K111743: The Insync Ceramic System

- Pathway: 510(k) (Abbreviated)
- Applicant: Jensen Industries, Inc.
- Decided: Sep 14, 2011 after 85 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: 3 generations back to K024250 (2003). 5 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043221: Willi Geller Creation CP Porcelain, Jensen Industries, Inc. (2004) Summary page 1.
- K070114: Creation CP-ZI Porcelain, Jensen Industries, Inc. (2007) Summary page 1.

## Most influential descendants
- K141400: Dcceram System (2015), 3 descendants of its own
- K193588: DD Contrast (2020), 1 descendant of its own
- 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
- K231264: Easy On Universal Glaze & Stain (2023), 0 descendants of its own

## Indications for use
The pressable ceramic pellets are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and the ceramic layering porcelain and liquids are used to build up the pressed ceramic to final tooth morphology and shade. The ceramic layering porcelain and liquids are also used in building ceramic crowns and bridges on titanium and titanium alloy substructures. Both applications are to provise protheses for missing / damaged teeth.

Source page: https://510kreport.com/device/K111743
Methodology: https://510kreport.com/methodology