# K980018: Cristobal

- Pathway: 510(k) (Traditional)
- Applicant: Newave Medical, Inc.
- Decided: May 19, 1998 after 137 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: 1 generation back to K831215 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831215: Dentacolor Light Curing Crown & Bridge, Kulzer, Inc. (1983) Summary page 1.
- K954115: Artglass & Kevloc, Heraeus Kulzer, Inc. (1995) Summary page 1.

## Indications for use
To construct cosmetic prosthetic dental restoratives for use in fixed restorations with or without metal frameworks to include: single crowns, telescope crowns, CONus crowns, bridges, Maryland bridges, bridges on implants, inlays, onlays facettes (laminate veneers), and restorations.

Source page: https://510kreport.com/device/K980018
Methodology: https://510kreport.com/methodology