# K053438: Glass Ceramics

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe AG Dental Products
- Decided: Jan 18, 2006 after 40 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: 1 generation back to K980986 (1998). 2 ancestors in all.
19 later devices descend from it; 5 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980986: Procad, Ivoclar USA, Inc. (1998) Summary page 2.
- K022408: Cerec Vitablocks MK2, B.B.'S Prophy Shop (2002) Summary page 2.

## Cited in the summary but kept off the family tree
- K0113949: Lava CeramicM / Lava FrameTM. Number could not be read
- K9204259: Paradigm TM MZ 100 block. Number could not be read Summary page 2.

## Most influential descendants
- K063511: Ceramill ZI (2007), 12 descendants of its own
- K092513: Rainbow Block (2009), 5 descendants of its own
- K152383: Ceramill Zolid FX (2015), 3 descendants of its own
- K151842: Rainbow Shine (2016), 2 descendants of its own
- K170050: Z-CAD smile (2018), 1 descendant of its own

## Indications for use
Manufacture of all-ceramic inlays, onlays, crowns, and veneers.

Source page: https://510kreport.com/device/K053438
Methodology: https://510kreport.com/methodology