# K042548: Cerasys - ZR

- Pathway: 510(k) (Traditional)
- Applicant: Cerasys, Inc.
- Decided: Dec 3, 2004 after 74 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: 4 generations back to K830955 (1983). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013230: Cercon Base, Degussa - Ney Dental, Inc. (2001) Summary page 1.
- K023327: Cynovad Zirkon, Cynovad (2002) Summary page 1.
- K984201: Denzir, Dentronic AB (1999) Summary page 1.
- K011394: Lava Frame, Lava Frame Shade, Lava Ceram, Espe Dental AG (2001)
- K001815: DC Zirkon, Austenal, Inc. (2000) Summary page 1.
- K973221: Composite 168 Restorative System, Dentsply Intl. (1998) Summary page 1.
- K971869: Finesse All-Ceramic System, Dentsply Intl. (1997) Summary page 1.
- K943168: Clearfil AP-X, Kuraray Company, Ltd. (1994) Summary page 1.

## Indications for use
Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II,V (Inlays & Onlays) and as a restorative material intended for veneers, crowns, and bridges.

Source page: https://510kreport.com/device/K042548
Methodology: https://510kreport.com/methodology