# K133824: Cerasmart

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Mar 14, 2014 after 87 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 K042819 (2004). 10 ancestors in all.
32 later devices descend from it; 5 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110131: Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative, 3M Espe Dental Products (2011) Summary page 2.
- K123631: MFP-051, GC America, Inc. (2013) Summary page 2.
- K082171: Gradia Core, GC America, Inc. (2008) Summary page 1.

## Most influential descendants
- K160425: CAD/CAMouflage Milling Bock (2016), 26 descendants of its own
- K162537: CAD/CAMouflage Milling Block (2016), 25 descendants of its own
- K201668: VarseoSmile Crown plus (2020), 24 descendants of its own
- K202846: Tera Harz (2021), 13 descendants of its own
- K210977: E-Dent 1000 (2021), 7 descendants of its own

## Indications for use
The product is indicated for inlays, onlays, veneers and full crown restorations, including crowns an implants.

Source page: https://510kreport.com/device/K133824
Methodology: https://510kreport.com/methodology