# K101814: Direct Crown Natural 1

- Pathway: 510(k) (Traditional)
- Applicant: Candulor USA, Inc.
- Decided: Sep 27, 2010 after 90 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Direct Crown Natural 1 is intended for the fabrication of short and long term temporary crowns and bridges (up to 12 months) using the Direct Crown shell teeth.

Source page: https://510kreport.com/device/K101814
Methodology: https://510kreport.com/methodology