# K052097: Ceram X Universal Mano-Ceramic Restorative

- Pathway: 510(k) (Special)
- Applicant: Dentsply International
- Decided: Aug 12, 2005 after 9 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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 K863092 (1986). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984387: R-30 Aesthetic Restorative, Dentsply Intl. (1999) Summary page 1.

## Most influential descendants
- K080305: Nexcomp and Meta Etchant (2008), 1 descendant of its own
- K181689: Nexcomp (2018), 0 descendants of its own

## Indications for use
UNIVERSAL NANO-CERAMICTM RESTORATIVE is indicated for direct restorations of all cavity classes in anterior and posterior teeth.

Source page: https://510kreport.com/device/K052097
Methodology: https://510kreport.com/methodology