# K122269: Enamic

- Pathway: 510(k) (Abbreviated)
- Applicant: Vita Zahnfabrik H.Rauter GmbH & Co.
- Decided: Dec 13, 2012 after 136 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: 2 generations back to K920425 (1992). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102128: Vitablocs, Vita Zahnfabrik H.Rauter GmbH & Co. (2010) Summary page 1.
- K110131: Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative, 3M Espe Dental Products (2011) Summary page 1.

## Most influential descendants
- K243940: VITA YZ Multi Translucent (2025), 0 descendants of its own
- K153645: VITA ENAMIC Implant Solutions (IS) (2016), 0 descendants of its own
- K130654: Crystal Ultra (2013), 0 descendants of its own

## Indications for use
EnamicO is indicated for use as a dental restoration including inlays, onlays, veneers, and crowns.

Source page: https://510kreport.com/device/K122269
Methodology: https://510kreport.com/methodology